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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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BTK,QC Combat Gauze,SWAT-T
Z-MEDICA, LLC
0499
In Commercial Distribution

  • 00841495104992 ()
0499

  • Non-organic haemostatic agent
BTK, Combat Gauze LE
Z-MEDICA, LLC
0261
In Commercial Distribution

  • 00841495102615 ()
0261

  • Non-organic haemostatic agent
Geenius SW V2.0 & APF V2.0 Installation Kit
Bio-RAD Laboratories, Inc.
12012851
In Commercial Distribution

  • 03610522168064 ()

  • 1 Each
12012851

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Software V2.0 LIS Guide, US only
Bio-RAD Laboratories, Inc.
12012484
In Commercial Distribution

  • 03610522162260 ()

  • 1 Each
12012484

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius Blood Donor IFU & APF v2.0 binder
Bio-RAD Laboratories, Inc.
12012482
In Commercial Distribution

  • 03610522162239 ()

  • 1 each
12012482

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
Geenius HIV 1/2 Supplemental Assay 20t
Bio-RAD Laboratories, Inc.
72480
In Commercial Distribution

  • 03610521168942 ()

  • 20 Tests
72480

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay
In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access + inflation device
Coloplast A/S
BD3020
In Commercial Distribution

  • 03600040325087 ()

  • Outer Diameter: 10 Millimeter
  • Length: 55 Centimeter
BD3020

  • Endoscopic-access dilator, single-use
In-Ka® Percutaneous Balloon Dilatation Catheter Balloon dilation catheter for percutaneous access
Coloplast A/S
BD3010
In Commercial Distribution

  • 03600040325056 ()

  • Outer Diameter: 10 Millimeter
  • Length: 55 Centimeter
BD3010

  • Endoscopic-access dilator, single-use
Urinary Diversion Stent
BOSTON SCIENTIFIC CORPORATION
M0061605350
Not in Commercial Distribution

  • 08714729880370 ()

  • 8 F Stent Diameter
  • 80 cm Effective Length
  • 2.7 mm Stent Diameter


  • Polymeric ureteral stent
Urinary Diversion Stent
BOSTON SCIENTIFIC CORPORATION
M0061605300
Not in Commercial Distribution

  • 08714729880363 ()

  • 80 cm Effective Length
  • 7 F Stent Diameter
  • 2.3 mm Stent Diameter


  • Polymeric ureteral stent
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