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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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VIABAHN SX ENDO HEPARIN 35 5mmX10cm 7Fr 120cmCath
W. L. Gore & Associates, Inc.
VBH051002
Not in Commercial Distribution

  • 00733132614783 ()

  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 10 Centimeter
VBH051002

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 5mmX5cm 7Fr 120cmCath
W. L. Gore & Associates, Inc.
VBH050502
Not in Commercial Distribution

  • 00733132614776 ()

  • Length: 5 Centimeter
  • Lumen/Inner Diameter: 5 Millimeter
VBH050502

  • Peripheral artery endovascular stent-graft, drug-coated
VIABAHN SX ENDO HEPARIN 35 5mmX2.5cm 7Fr120cmCath
W. L. Gore & Associates, Inc.
VBH050202
Not in Commercial Distribution

  • 00733132614769 ()

  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 2.5 Centimeter
VBH050202

  • Peripheral artery endovascular stent-graft, drug-coated
Guideline 2005 Exch, FR2+ ECG, Philips
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861364
Not in Commercial Distribution

  • 00884838050723 ()
861364

  • Non-rechargeable public automated external defibrillator
HS Refurbished FR2+ AED, with ECG
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861458
Not in Commercial Distribution

  • 00884838050389 ()
861458

  • Non-rechargeable public automated external defibrillator
No Description
CAPTIVA SPINE, INC.
PI-0706
In Commercial Distribution

  • M739PI0706 ()


  • Bone curette, reusable
No Description
CAPTIVA SPINE, INC.
PI-0705
In Commercial Distribution

  • M739PI0705 ()


  • Bone curette, reusable
No Description
CAPTIVA SPINE, INC.
PI-0704
In Commercial Distribution

  • M739PI0704 ()


  • Bone curette, reusable
Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle.
IRVINE SCIENTIFIC, LLC
9983-500ML
In Commercial Distribution

  • 00810195240804 ()
9983

  • IVF medium
CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99404-100ML
In Commercial Distribution

  • 00810195240583 ()
99404

  • Cell culture medium IVD
Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
IRVINE SCIENTIFIC, LLC
90126-500ML
In Commercial Distribution

  • 00810195240439 ()
90126

  • IVF medium
Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
IRVINE SCIENTIFIC, LLC
90126-100ML
In Commercial Distribution

  • 00810195240422 ()
90126

  • IVF medium
Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
IRVINE SCIENTIFIC, LLC
9983-100ML
In Commercial Distribution

  • 00810195240170 ()
9983

  • IVF medium
Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 10% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90123-5x0.5ML
In Commercial Distribution

  • 00810195240132 ()
90123

  • IVF medium
Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90121-5x0.5ML
In Commercial Distribution

  • 00810195240125 ()
90121

  • IVF medium
No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00887868480911 ()
31-473621

  • Surgical mallet
Suction bag with solidifier, 2.5l used with disposable collection system
Medela AG
077.0087
In Commercial Distribution

  • 07612367031738 ()
  • 07612367031356 ()
  • 00761236701382 ()


  • Suction system canister liner
Suction bag with solidifier 1.5l for disposable collection system
Medela AG
077.0084
In Commercial Distribution

  • 07612367031714 ()
  • 07612367031332 ()
  • 07612367013796 ()


  • Suction system canister liner
Canister for thoracic suction systempump
Medela AG
079.0012
In Commercial Distribution

  • 07612367038669 ()
  • 07612367014212 ()
  • 07612367063364 ()


  • Surgical suction system collection container, single-use
Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path.
FENWAL, INC.
4R2441
Not in Commercial Distribution

  • 10811137012418 ()
  • 00811137012411 ()
4R2441

  • Apheresis system tubing set
No Description
Biomet Orthopedics, LLC
909849
In Commercial Distribution

  • 00887868572548 ()
909849

  • Ligament reconstruction instrument set, reusable
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-07
In Commercial Distribution

  • 00810929014879 ()
  • 00810929014787 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-13
In Commercial Distribution

  • 00810929010550 ()
  • 00810929010543 ()


  • Medical device cleaning agent
Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-16
In Commercial Distribution

  • 00810929010345 ()
  • 00810929010338 ()


  • Medical device cleaning agent
Instrument kit contains quantity of 1 each: Perpos 2 in 1 Drill, Perpos K-Wire, Perpos Pull Pin Remover, Perpos Tap, Perpos Device Driver, Perpos Compression Tool, Tray Assembly
INTERVENTIONAL SPINE, INC
9039-02
Not in Commercial Distribution

  • 81195401009648 ()
9039-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable
A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution

  • 72900130302906 ()
CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical
PEDICLE AWL, STRAIGHT WITH TROCAR
Si-Bone Inc.
502206
In Commercial Distribution

  • 00810055524747 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
TAPESTRY Biointegrative Implant with Introducer, Lateral, 26mm x 26mm
Embody, Inc.
TR-2626-31
In Commercial Distribution

  • 00810063820466 ()
TR-2626-31

  • Extra-gynaecological surgical mesh, biologic-polymer composite
TAPESTRY Biointegrative Implant with Introducer, Anterior, 26mm x 26mm
Embody, Inc.
TR-2626-21
In Commercial Distribution

  • 00810063820459 ()
TR-2626-21

  • Extra-gynaecological surgical mesh, biologic-polymer composite
TAPESTRY Biointegrative Implant with Introducer, Lateral, 40mm x 30mm
Embody, Inc.
TR-4030-31
In Commercial Distribution

  • 00810063820145 ()
TR-4030-31

  • Extra-gynaecological surgical mesh, biologic-polymer composite
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