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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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Simpurity - 00810040131448

Simpurity Silver Silicone Adhesive Border Multi- Layered Foam Dressing 2" x 2"
SAFE N' SIMPLE LLC
SNS77122
In Commercial Distribution

  • 00810040131455 ()
  • 00810040131448 ()
  • 00810040131462 ()

  • Width: 2 Inch
  • Length: 2 Inch
SNS77122

  • Wound-nonadherent dressing, absorbent, antimicrobial

Avalign - 00190776001636

Mayo Swivel Retractor
Avalign Technologies, Inc.
VM02-84897
In Commercial Distribution

  • 00190776001636 ()

  • Length: 2 Inch
  • Width: 2 Inch


  • Surgical retractor/retraction system blade, reusable

Pilling - 00190776025885

Pediatric Mayo Retractor Blade Bladder
Avalign Technologies, Inc.
P14206
Not in Commercial Distribution

  • 00190776025885 ()

  • Length: 2 Inch
  • Width: 2 Inch


  • Surgical retractor/retraction system blade, reusable

Uni-Patch - 00884521582104

C Series Spunlace Electrodes O-T-C
Cardinal Health, Inc.
EP85875
Not in Commercial Distribution

  • 00884521582111 ()
  • 00884521582104 ()
  • 00884521746124 ()

  • Length: 2 Inch
  • Width: 2 Inch
EP85875

  • Transcutaneous electrical stimulation electrode, single-use

Curity - 00884521060503

All Purpose Sponges,Non-woven, 4 Ply
Cardinal Health, Inc.
9022
In Commercial Distribution

  • 00884521060510 ()
  • 00884521060503 ()
  • 00884521779405 ()

  • Width: 2 Inch
  • Length: 2 Inch
9022

  • Non-woven gauze pad

CARDINAL HEALTH ESSENTIALS - 00885380108269

Reinforced Silver Calcium Alginate/CMC Dressing; Reinforced Pad; 2 in. x 2 in.
RGH ENTERPRISES
ZSCA22RF
In Commercial Distribution

  • 20885380108263 ()
  • 00885380108269 ()
  • 50885380108264 ()

  • Length: 2 Inch
  • Width: 2 Inch
ZSCA22RF

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

Uni-Patch - 00884521582142

C Series Foam Electrode O-T-C
Cardinal Health, Inc.
EP85879
In Commercial Distribution

  • 00884521582159 ()
  • 00884521582142 ()
  • 00884521746148 ()

  • Width: 2 Inch
  • Length: 2 Inch
EP85879

  • Transcutaneous electrical stimulation electrode, single-use

Uni-Patch - 00884521582005

C Series Stimulating Electrodes O-T-C
Cardinal Health, Inc.
EP85863
In Commercial Distribution

  • 00884521582012 ()
  • 00884521582005 ()
  • 00884521746155 ()

  • Width: 2 Inch
  • Length: 2 Inch
EP85863

  • Transcutaneous electrical stimulation electrode, single-use

Rotium Bioresorbable Wick - 00852513007058

No Description
NANOFIBER SOLUTIONS, INC.
FG-0007
In Commercial Distribution

  • 20852513007052 ()
  • 10852513007055 ()
  • 00852513007058 ()

  • Width: 2 Centimeter
  • Length: 2 Centimeter


  • Tendon/ligament bone anchor, bioabsorbable

Situate - 10884521700765

Gauze - RF and X-ray Detectable USP Type VII, 8 Ply
Covidien LP
G0202-08P01C-1
In Commercial Distribution

  • 20884521700762 ()
  • 10884521700765 ()
  • 30884521700769 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Radiopaque woven surgical sponge

Situate - 30884521700776

Gauze-RF and X-ray Detectable USP Type VII, 8 Ply. Caution: For Manufacturing, Processing or Repacking.
Covidien LP
G0202-08P01CN-1
In Commercial Distribution

  • 20884521700779 ()
  • 30884521700776 ()
  • 50884521700770 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Radiopaque woven surgical sponge

N/A - 00382903408818

Anti-HER-2/neu APC Neu 24.7 ASR
BECTON, DICKINSON AND COMPANY
340881
Not in Commercial Distribution

  • 00382903408818 ()
340881

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

N/A - 00382903408801

Anti-HER-2/neu FITC Neu 24.7 ASR
Becton, Dickinson And Company
340880
In Commercial Distribution

  • 00382903408801 ()
340880

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

N/A - 00382903408795

Anti-HER-2/neu PE Neu 24.7 ASR
Becton, Dickinson And Company
340879
In Commercial Distribution

  • 00382903408795 ()
340879

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

ADVIA Centaur® H2n Calibrator - 00630414471228

HER-2/Neu - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308993
In Commercial Distribution

  • 00630414471228 ()
913551

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, calibrator

ADVIA Centaur® H2n QC - 00630414471211

HER-2/Neu - CENTAUR - CONS - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10308992
In Commercial Distribution

  • 00630414471211 ()
913276

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

ADVIA Centaur® H2n MCM - 00630414469850

HER-2/NEU Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10324496
In Commercial Distribution

  • 00630414469850 ()
131217

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

Novocastra™ - 05055331315304

NCL-L-CB11 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CB11-L-CE
In Commercial Distribution

  • 05055331315304 ()
NCL-L-CB11

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

Novocastra™ - 05055331315229

NCL-L-CBE-356 is intended for the qualitative identification by light microscopy of c-erbB-2 Oncoprotein molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
CBE-356-L-CE
In Commercial Distribution

  • 05055331315229 ()
NCL-L-CBE-356

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

BOND™ - 05055331336712

c-erbB-2 Oncoprotein (CB11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of c-erbB-2 oncoprotein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0983-U
In Commercial Distribution

  • 05055331336712 ()
PA0983-U

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
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