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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This product is composed of cathode, anode and glass shell.The product is suitable for medical diagnostic X-ray machine.
MingWei Medical Technology(Suzhou)Co.,LTD
MWTX77-0.7/1.3-130
In Commercial Distribution

  • 16973915530010 ()


  • X-ray system tube
This product is composed of cathode,anode and glass shell.The product is suitable for medical diagnostic X-ray machine.
MingWei Medical Technology(Suzhou)Co.,LTD
MWTX77-0.7/1.3-135
In Commercial Distribution

  • 16973915530003 ()


  • X-ray system tube
The specfication of electrodes is 50*50 and it is packed with color box (40 pieces) bold line
Wuxi Jiajian Medical Instrument Co.,Ltd.
11A-1806-L
In Commercial Distribution

  • 16972011716519 ()
  • 06972011716512 ()


  • Acupuncture needle, single-use
The specfication of electrodes is 50*50 and it is packed with shading bag (40 pieces) bold line
Wuxi Jiajian Medical Instrument Co.,Ltd.
11A-1806-L
In Commercial Distribution

  • 16972011716502 ()
  • 06972011716505 ()


  • Acupuncture needle, single-use
The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit.
Ascension Orthopedics, Inc.
MGT89040MT
In Commercial Distribution

  • 10381780116462 ()
  • M268MGT89040MT1 ()

  • .686 in L; Size 40
MGT89040MT

  • Total metatarsophalangeal joint prosthesis, one-piece
The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit.
Ascension Orthopedics, Inc.
MGT89030MT
In Commercial Distribution

  • 10381780116448 ()
  • M268MGT89030MT1 ()

  • .646 in L; Size 30
MGT89030MT

  • Total metatarsophalangeal joint prosthesis, one-piece
The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit.
Ascension Orthopedics, Inc.
MGT89020MT
In Commercial Distribution

  • 10381780116424 ()
  • M268MGT89020MT1 ()

  • .606 in L; Size 20
MGT89020MT

  • Total metatarsophalangeal joint prosthesis, one-piece
The Integra Movement Great Toe System metatarsal component is designed for resurfacing the 1st metatarsal head. The component is an anatomically designed, monolithic device.The device is made from cobalt chromium alloy with a commercially pure titanium plasma spray. The metatarsal is intended as hemi-arthroplasty at the surface and is a press-fit.
Ascension Orthopedics, Inc.
MGT89010MT
In Commercial Distribution

  • 10381780116400 ()
  • M268MGT89010MT1 ()

  • .566 in L; Size 10
MGT89010MT

  • Total metatarsophalangeal joint prosthesis, one-piece
GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration.
IMMUCOR, INC.
0007058
In Commercial Distribution

  • 10888234000716 ()
0007058

  • Bromelin immunohaematology reagent IVD
Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is for Self Mixing dispensing in Blue Shade. This is a Non-Fluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
1NFSMBLB
In Commercial Distribution

  • D7981NFSMBLB0 ()
1NFSMBLB

  • Dental composite resin
Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is for Self Mixing dispensing in Blue Shade. This is a Non-Fluoride Device
RELIANCE ORTHODONTIC PRODUCTS INC
NFSMBLB
In Commercial Distribution

  • D798NFSMBLB0 ()
NFSMBLB

  • Dental composite resin
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2722
In Commercial Distribution

  • 10381780117452 ()
  • M268AQ27221 ()

  • 1.732 in L x .107 in dia; .866 in thread
AQ2722

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2720
In Commercial Distribution

  • 10381780117445 ()
  • M268AQ27201 ()

  • 1.654 in L x .107 in dia; .787 in thread
AQ2720

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2718
In Commercial Distribution

  • 10381780117438 ()
  • M268AQ27181 ()

  • 1.575 in L x .107 in dia; .709 in thread
AQ2718

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2716
In Commercial Distribution

  • 10381780117421 ()
  • M268AQ27161 ()

  • 1.496 in L x .107 in dia; .630 in thread
AQ2716

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2714
In Commercial Distribution

  • 10381780117414 ()
  • M268AQ27141 ()

  • 1.417 in L x .107 in dia; .551 in thread
AQ2714

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2712
In Commercial Distribution

  • 10381780117407 ()
  • M268AQ27121 ()

  • 1.339 in L x .107 in dia; .472 in thread
AQ2712

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2016
In Commercial Distribution

  • 10381780117391 ()
  • M268AQ20161 ()

  • 1.496 in L x .083 in dia; .630 in thread
AQ2016

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2014
In Commercial Distribution

  • 10381780117384 ()
  • M268AQ20141 ()

  • 1.417 in L x .083 in dia; .551 in thread
AQ2014

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2012
In Commercial Distribution

  • 10381780117377 ()
  • M268AQ20121 ()

  • 1.339 in L x .083 in dia; .472 in thread
AQ2012

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2011
In Commercial Distribution

  • 10381780117360 ()
  • M268AQ20111 ()

  • 1.299 in L x .083 in dia; .433 in thread
AQ2011

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2010
In Commercial Distribution

  • 10381780117353 ()
  • M268AQ20101 ()

  • 1.260 in L x .083 in dia; .394 in thread
AQ2010

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Capture QuickSnap screw is a snap-off solid core screw is made from titanium and is used for bone fixation of the hand and foot, following trauma or osteotomy.
Ascension Orthopedics, Inc.
AQ2008
In Commercial Distribution

  • 10381780117346 ()
  • M268AQ20081 ()

  • 1.181 in L x .083 in dia; .312 in thread
AQ2008

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
N3160082
In Commercial Distribution

  • 00812589020566 ()
N3160082

  • Atomic absorption spectrophotometer IVD, semi-automated
For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
N3160060
In Commercial Distribution

  • 00812589020559 ()
N3160060

  • Atomic absorption spectrophotometer IVD, semi-automated
For use in clinical applications; identification is according to the wavelength and intensity of the light that is absorbed when the specimen is converted to the atomic vapor phase.
REVVITY SINGAPORE PTE. LTD.
N3160051
In Commercial Distribution

  • 00812589020542 ()
N3160051

  • Atomic absorption spectrophotometer IVD, semi-automated
The Canady Hybrid Plasma GIT probe is an electrosurgical plasma probe that is 2.3mm in diameter and 3.4m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422541
In Commercial Distribution

  • B413AW4225410 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use
This Blue Diamond® Gel pad is an overlay that is the full length of an OR Table. Our made in the USA gel is ideal for pressure management.
David Scott Company
BD2110-25
In Commercial Distribution

  • 15060797551262 ()

  • Width: 20 Inch
  • Length: 72 Inch
  • Height: .25 Inch
BD2110-25

  • Operating table patient pressure distribution pad, reusable
This Blue Diamond® Gel pad is an overlay that is the full length of an OR Table. Our made in the USA gel is ideal for pressure management.
David Scott Company
BD2110
In Commercial Distribution

  • 15060797551255 ()

  • Width: 20 Inch
  • Length: 72 Inch
  • Height: .5 Inch
BD2110

  • Operating table patient pressure distribution pad, reusable
This Blue Diamond® Gel pad is an overlay that is approximately 3/4 Length Gel Table Pad. Our made in the USA gel is ideal for pressure management.
David Scott Company
BD2100
In Commercial Distribution

  • 15060797551248 ()

  • Width: 20 Inch
  • Length: 46 Inch
  • Height: .5 Inch
BD2100

  • Operating table patient pressure distribution pad, reusable
ImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software and Laboratory Information System. ImmuLINK includes the following features and/or functions: It provides the ability to create and print reports of tests and results. It supports the ability to compare current results with previous results. It supports the automatic ordering of reflex tests. It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. It provides bi-directional communication with LIS and instrument platform(s).
IMMUCOR, INC.
0064319
In Commercial Distribution

  • 10888234001034 ()
0064319

  • Blood bank information system application software
The SonoScape Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The SonoScape Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
210781
In Commercial Distribution

  • 00852656007519 ()


  • Medical table clamp
The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis-NG Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
210509
In Commercial Distribution

  • 00852656007489 ()


  • Medical table clamp
The Sonalis Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
210222
In Commercial Distribution

  • 00852656007151 ()


  • Medical table clamp
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6211
In Commercial Distribution

  • 00852656007144 ()


  • Medical table clamp
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6058
In Commercial Distribution

  • 00852656007137 ()


  • Medical table clamp
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6057
In Commercial Distribution

  • 00852656007120 ()


  • Medical table clamp
The Hitachi Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Hitachi Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6056
In Commercial Distribution

  • 00852656007113 ()


  • Medical table clamp
The Aloka Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Aloka Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6055
In Commercial Distribution

  • 00852656007106 ()


  • Medical table clamp
The Siemens Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Siemens Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
Best Nomos
6054
In Commercial Distribution

  • 00852656007090 ()


  • Medical table clamp
corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies.
IMMUCOR, INC.
0002400
In Commercial Distribution

  • 10888234000334 ()
0002400

  • Multiple immunohaematology test IVD, control
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 5-6.5 MM
In Commercial Distribution

  • 03701444300257 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications
CORNING SAS
CORNING® MED-X ® GLASS - 5.7-7 MM
In Commercial Distribution

  • 03701444300240 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications
CORNING SAS
CORNING® MED-X ® GLASS - 7-8.5 MM
In Commercial Distribution

  • 03701444300233 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 8.5-10 MM
In Commercial Distribution

  • 03701444300226 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 10-12 MM
In Commercial Distribution

  • 03701444300219 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 11-13 MM
In Commercial Distribution

  • 03701444300202 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 12-14 MM
In Commercial Distribution

  • 03701444300196 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 14-16 MM
In Commercial Distribution

  • 03701444300189 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
Corning® Med-X ® Glass is a glass plate that is used for Xray radiation attenuation. it is used to protect operators in medical environment, industrial and research laboratory. it is either used fixed as a window or in mobile applications.
CORNING SAS
CORNING® MED-X ® GLASS - 16-18 MM
In Commercial Distribution

  • 03701444300172 ()


  • Radiation shielding panel, fixed
  • Radiation shielding panel, portable/mobile
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