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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Myron L® Company - 00857744006122

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, Gallon
In Commercial Distribution

  • 00857744006122 ()

  • Total Volume: 1 Gallon
NACL-14.0G

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006115

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, Quart
In Commercial Distribution

  • 00857744006115 ()

  • Total Volume: 1 Quart
NACL-14.0Q

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006108

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 14.0 Millimhos, 2 Ounces
In Commercial Distribution

  • 00857744006108 ()

  • Total Volume: 2 Fluid Ounce
NACL-14.02OZ

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006092

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 13.4 Millimhos, Gallon
In Commercial Distribution

  • 00857744006092 ()

  • Total Volume: 1 Gallon
NACL-13.4G

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006085

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 13.4 Millimhos, Quart
In Commercial Distribution

  • 00857744006085 ()

  • Total Volume: 1 Quart
NACL-13.4Q

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006078

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 12.5 Millimhos, Gallon
In Commercial Distribution

  • 00857744006078 ()

  • Total Volume: 1 Gallon
NACL-12.5G

  • Haemodialysis conductivity standard solution

Myron L® Company - 00857744006061

NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.
MYRON L COMPANY
Solution, NaCl, 12.5 Millimhos, Quart
In Commercial Distribution

  • 00857744006061 ()

  • Total Volume: 1 Quart
NACL-12.5Q

  • Haemodialysis conductivity standard solution

Accell TBM - 10889981055653

Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-550
In Commercial Distribution

  • M3860240005501 ()
  • 10889981055653 ()

  • 5cmx5cm
02-4000-550

  • Bone matrix implant, human-derived

Accell TBM - 10889981055646

Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-520
In Commercial Distribution

  • M3860240005201 ()
  • 10889981055646 ()

  • 5cmX2cm
02-4000-520

  • Bone matrix implant, human-derived

Zap-X Treatment Planning Software - 00860183001528

The Zap-X Treatment Planning Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300152
In Commercial Distribution

  • 00860183001528 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system

Zap-X Treatment Delivery Software - 00860183001511

The Zap-X Treatment Delivery Software is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300151
In Commercial Distribution

  • 00860183001511 ()


  • Stereotactic radiosurgery/radiation therapy linear accelerator system

Gamma N-HANCE - 10888234001812

Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0705410
In Commercial Distribution

  • 10888234001812 ()
0705410

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Gamma N-HANCE - 10888234001805

Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the three (3) vial configuration.
IMMUCOR, INC.
0705403
In Commercial Distribution

  • 10888234001805 ()
0705403

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Crown Lok - D798SMCLBK0

Crown Lok is intended for use as a cement for metal crowns and orthodontic bands. This is the Self Mixing kit that includes 60 self mixing tips. The adhesive is blue shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMCLBK
Not in Commercial Distribution

  • D798SMCLBK0 ()
SMCLBK

  • Dental prosthesis veneer resin

Band Lok - D798SMBLK0

Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing Kit that includes 60 self mixing tips. The adhesive is natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMBLK
Not in Commercial Distribution

  • D798SMBLK0 ()
SMBLK

  • Dental composite resin

Band Lok - D798SMBLBK0

Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing Kit that includes 60 self mixing tips. The adhesive is blue shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMBLBK
Not in Commercial Distribution

  • D798SMBLBK0 ()
SMBLBK

  • Dental composite resin

AbbVie Hip Pack - 08054083007953

The Hip Pack is designed to carry a CADD-Legacy® 1400 pump. This Hip Pack is intended for single-patient use only. The Hip Pack is intended to be worn around the waist.
ABBVIE INC.
10637
In Commercial Distribution

  • 38054083007954 ()
  • 08054083007953 ()


  • Personal device holder, reusable

OWANDY - 03760278264920

"The MINI DOCK USB2 module is built-in docking station for SOPROCARE, SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
MINI DOCK OWANDY-CAM HD
In Commercial Distribution

  • 03760278264920 ()
S_ODOCK_0001

  • Diagnostic-imaging multiformat camera

ACTEON - 03760278260090

"The MINI DOCK USB2 module is built-in docking station for SOPROCARE, SOPROLIFE, SOPRO 617 and SOPRO 717 First cameras. This product is designed for dental applications and is not intended for diagnosis."
SOPRO
MINI DOCK USB2 STRAUMANN
In Commercial Distribution

  • 03760278260090 ()
S_717_1601

  • Diagnostic-imaging multiformat camera

Trel X-Press 100 - 10381780112532

Trel-XPress 100, 2.5cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES125
In Commercial Distribution

  • M386XPRES1251 ()
  • 10381780112532 ()

  • 2.5cc
XPRES125

  • Bone matrix implant, human-derived

Trel X-Press 100 - 10381780112525

Trel-XPress 100, 5cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES105
In Commercial Distribution

  • M386XPRES1051 ()
  • 10381780112525 ()

  • 5cc
XPRES105

  • Bone matrix implant, human-derived

Trel X-Press 100 - 10381780112518

Trel-XPress 100, 10cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES110
In Commercial Distribution

  • M386XPRES1101 ()
  • 10381780112518 ()

  • 10cc
XPRES110

  • Bone matrix implant, human-derived

Hallu®- LOCK - 10381780042631

The HALLU® LOCK 10° C plate rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299933ND
Not in Commercial Distribution

  • M248299933ND1 ()
  • 10381780042631 ()


  • Device sterilization/disinfection container, reusable

Hallu®- LOCK - 10381780042624

The HALLU® LOCK 5° S plate rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299932ND
Not in Commercial Distribution

  • M248299932ND1 ()
  • 10381780042624 ()


  • Device sterilization/disinfection container, reusable

Hallu®- LOCK - 10381780042617

The HALLU® LOCK 10° S plate rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299931ND
Not in Commercial Distribution

  • M248299931ND1 ()
  • 10381780042617 ()


  • Device sterilization/disinfection container, reusable

Hallu®- LOCK - 10381780042549

The SURFIX® ALPHA 3.0 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299924ND
Not in Commercial Distribution

  • M248299924ND1 ()
  • 10381780042549 ()


  • Device sterilization/disinfection container, reusable

Hallu®- LOCK - 10381780042532

The SURFIX® ALPHA 2.7 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299923ND
Not in Commercial Distribution

  • M248299923ND1 ()
  • 10381780042532 ()


  • Device sterilization/disinfection container, reusable

Acrylic Block - 14560227799079

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-C
Not in Commercial Distribution

  • 14560227799079 ()
  • 04560227799072 ()
  • 24560227799076 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS23US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799055

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and coler type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-B
Not in Commercial Distribution

  • 14560227799055 ()
  • 04560227799058 ()
  • 24560227799052 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 109 Millimeter
TS15US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799048

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and coler type is Pink
SUN MEDICAL CO.,LTD.
MCL-011-B
Not in Commercial Distribution

  • 14560227799048 ()
  • 04560227799041 ()
  • 24560227799045 ()

  • Depth: 30 Micrometer
  • Outer Diameter: 109 Millimeter
TS13US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799031

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 109 mm diameter x 30 mm depth, and color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-B
Not in Commercial Distribution

  • 14560227799031 ()
  • 04560227799034 ()
  • 24560227799038 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 109 Millimeter
TS11US

  • Dental appliance fabrication material, thermoplastic

Optimos™ Cystotome - 08809909406423

The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1908
In Commercial Distribution

  • 08809909406423 ()
OCT1908

  • Endoscopic electrosurgical electrode, monopolar, single-use

Optimos™ Cystotome - 08809909406416

The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1907
In Commercial Distribution

  • 08809909406416 ()
OCT1907

  • Endoscopic electrosurgical electrode, monopolar, single-use

Optimos™ Cystotome - 08809909406409

The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1906
In Commercial Distribution

  • 08809909406409 ()
OCT1906

  • Endoscopic electrosurgical electrode, monopolar, single-use

TAUB - Trident - ECS (Expandable Crown Splitter) - D8379911500

ECS is a hand held and operated crown splitter. A vertical cut is made into the crown by a cutting wheel and the crown splitter is inserted into the cut. The splitter is squeezed and the unit tip separates and splits the crown open.
Taub Products
1 mm
In Commercial Distribution

  • D8379911500 ()
99-1150

  • Dental prosthesis removal instrument

Single Lens BillBoard - B222700

The 700 Single Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in., width is approximately 1.050 in. and height approximately 0.450 in. It has a single lens well and is paired with the Plain cap.
Paragon Vision Sciences, Inc.
700
In Commercial Distribution

  • B222700 ()
  • B2227009 ()


  • Contact lens case

SAMI Hemofiltration Cassette - B815SM2000030

The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SM-200-003
In Commercial Distribution

  • B815SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use

SAMI RRT Cassette - B815SA400000

The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use

SAMI Hemofiltration Cassette - B815SA300000

The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-300-00
In Commercial Distribution

  • B815SA300000 ()
SA-300-00

  • Haemodialysis blood tubing set, single-use

DIMI RRT Cassette - B815DI400000

The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
DI-400-00
In Commercial Distribution

  • B815DI400000 ()
DI-400-00

  • Haemodialysis blood tubing set, single-use

SAMI Hemofiltration Cassette - B173SM2000030

The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SM-200-003
Not in Commercial Distribution

  • B173SM2000030 ()
SM-200-003

  • Haemodialysis blood tubing set, single-use

SAMI RRT Cassette - B173SA400000

The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Spectral Medical Inc
SA-400-00
Not in Commercial Distribution

  • B173SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use

SAMI Cassette - 07540161930226

The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
I-Dialco Inc
SA-400-00
In Commercial Distribution

  • 07540161930226 ()
  • 17540161930223 ()
  • 27540161930220 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use

TAC PIN - 10381780052845

The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120025ND
Not in Commercial Distribution

  • M248120025ND1 ()
  • 10381780052845 ()

  • 1.6mm diam. x 25mm length
120025ND

  • Orthopaedic bone pin, non-bioabsorbable

TAC PIN - 10381780052838

The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120020ND
Not in Commercial Distribution

  • 10381780052838 ()
  • M248120020ND1 ()

  • 1.6mm diam. x 20mm length
120020ND

  • Orthopaedic bone pin, non-bioabsorbable

TAC PIN - 10381780052821

The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.
NEWDEAL
120015ND
Not in Commercial Distribution

  • M248120015ND1 ()
  • 10381780052821 ()

  • 1.6mm diam. x 15mm length
120015ND

  • Orthopaedic bone pin, non-bioabsorbable

ATOZ Mini-Screw - 08800197900686

The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1615 *6EA
In Commercial Distribution

  • 08800197900686 ()


  • Orthodontic anchoring screw

ATOZ Mini-Screw - 08800197900679

The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1613 *6EA
In Commercial Distribution

  • 08800197900679 ()


  • Orthodontic anchoring screw

ATOZ Mini-Screw - 08800197900655

The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1611 *4EA
In Commercial Distribution

  • 08800197900655 ()


  • Orthodontic anchoring screw

ATOZ Mini-Screw - 08800197900631

The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
MK Meditech Inc.
MKS-1610 *6EA
In Commercial Distribution

  • 08800197900631 ()


  • Orthodontic anchoring screw
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