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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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Freevent Connection strap - 07331791008238

Freevent Connection Strap is a clip with a string that is used to secure Freevent DualCare to the patient’s neckband.
Atos Medical AB
7746
In Commercial Distribution

  • 07331791016530 ()
  • 07331791008238 ()
7746

  • Tracheostomy tube speech valve

Capo Natural Set - ESDG2320551

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232055
In Commercial Distribution

  • ESDG2320551 ()


  • Dental composite resin

Capo Natural Bleach 2, 4 g - ESDG2320531

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232053
In Commercial Distribution

  • ESDG2320531 ()


  • Dental composite resin

Capo Natural Bleach 1, 4 g - ESDG2320521

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232052
In Commercial Distribution

  • ESDG2320521 ()


  • Dental composite resin

Capo Natural Incisal white, 4 g - ESDG2320511

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232051
In Commercial Distribution

  • ESDG2320511 ()


  • Dental composite resin

Capo Natural Incisal clear, 4 g - ESDG2320501

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232050
In Commercial Distribution

  • ESDG2320501 ()


  • Dental composite resin

Capo Natural Incisal medium, 4 g - ESDG2320491

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232049
In Commercial Distribution

  • ESDG2320491 ()


  • Dental composite resin

Capo Natural C 3, 4 g - ESDG2320481

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232048
In Commercial Distribution

  • ESDG2320481 ()


  • Dental composite resin

Capo Natural C 2, 4 g - ESDG2320471

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232047
In Commercial Distribution

  • ESDG2320471 ()


  • Dental composite resin

Capo Natural B 3, 4 g - ESDG2320461

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232046
In Commercial Distribution

  • ESDG2320461 ()


  • Dental composite resin

Capo Natural B 2, 4 g - ESDG2320451

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232045
In Commercial Distribution

  • ESDG2320451 ()


  • Dental composite resin

Capo Natural A 4, 4 g - ESDG2320441

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232044
In Commercial Distribution

  • ESDG2320441 ()


  • Dental composite resin

Capo Natural A 3.5, 4 g - ESDG2320431

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232043
In Commercial Distribution

  • ESDG2320431 ()


  • Dental composite resin

Capo Natural A 3, 4 g - ESDG2320421

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232042
In Commercial Distribution

  • ESDG2320421 ()


  • Dental composite resin

Capo Natural A 2, 4 g - ESDG2320411

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232041
In Commercial Distribution

  • ESDG2320411 ()


  • Dental composite resin

Capo Natural A 1, 4 g - ESDG2320401

Capo Natural is a light-curing composite containing ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques
Schütz Dental GmbH
232040
In Commercial Distribution

  • ESDG2320401 ()


  • Dental composite resin

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

FlowSense - 13770016085011

FlowSense (ref: A0000047) is the single use sensor used with EOlife (ref: AUS00055). FlowSense is the consumable of EOlife. FlowSense is sold in boxes of 10 units under the sales reference A0000044.
ARCHEON
A0000047
In Commercial Distribution

  • 13770016085011 ()
  • 23770016085018 ()


  • Pulmonary resuscitator, manual, single-use

LesionHunter(TM) Rotatable Nitinol Cold Snare - 06932503550079

Oval Snare loop, Rotatable, Coated spring tube, Nitinol wire Snare loop, Diameter of Snare loop is 20 mm, working length is 2300mm, the maximum outside diameter of the insertion part is 2.3mm
Micro-Tech (Nanjing) Co., Ltd.
CS2-22023231
In Commercial Distribution

  • 16932503550076 ()
  • 06932503550079 ()
  • 26932503550073 ()

  • Outer Diameter: 2.6 Millimeter
  • Length: 230 Centimeter


  • Mechanical-cutting endoscopic polypectomy snare

LesionHunter(TM) Rotatable Nitinol Cold Snare - 06932503550062

Oval Snare loop, Rotatable, Coated spring tube, Nitinol wire Snare loop, Diameter of Snare loop is 15 mm, working length is 2300mm, the maximum outside diameter of the insertion part is 2.3mm
Micro-Tech (Nanjing) Co., Ltd.
CS2-21523231
In Commercial Distribution

  • 16932503550069 ()
  • 06932503550062 ()
  • 26932503550066 ()

  • Outer Diameter: 2.3 Millimeter
  • Length: 230 Centimeter


  • Mechanical-cutting endoscopic polypectomy snare
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