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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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Geenius - 03610522168064

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 - 03610522162260

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 - 03610522162239

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 - 03610521168942

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

CELOX RAPID Z-Fold Gauze - 15060206631318

Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules with Chito-R technology. Dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by a trained emergency responder.
MEDTRADE PRODUCTS LIMITED
FG08839241
In Commercial Distribution

  • 15060206631318 ()
  • 75060206631310 ()

  • 3in x 2ft Z-fold
  • Length: 2 Feet
  • Width: 3 Inch
FG08839241

  • Chitosan haemostatic agent, professional, non-bioabsorbable

Curos Jet™ - 30707387773824

3M™ Curos™ Jet™ Disinfecting Cap for Needleless Connectors 270/Carton 20 Cartons/Case CFJ1-270
3M COMPANY
CFJ1-270
In Commercial Distribution

  • 50707387773828 ()
  • 30707387773824 ()
  • 00707387773823 ()
CFJ1-270

  • Luer-formatted disinfection cap

ARK™ Methotrexate II Calibrator - 00812101031186

ARK™ Methotrexate II Calibrator is intended for use in calibration of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0002-00
In Commercial Distribution

  • 00812101031186 ()
5071-0002-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator

Walgreens - 00311917046877

Walgreens Dental Guard For Nighttime Teeth Grinding (Bruxism) 2 Dental Guards, 1 Storage Case, 1 Fitting Tray
WALGREEN CO.
630109
In Commercial Distribution

  • 10311917046874 ()
  • 00311917046877 ()
  • 40311917046875 ()
SQN5494SB1

  • Mouthguard, reusable

Panoscreen EXTEND - 10888234002406

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Webcol - 10192253046205

Alcohol Prep, 2 Ply, Large, Made in USA, Saturated with 70% Isopropyl Alcohol, For external use only
Cardinal Health 200, LLC
5110
In Commercial Distribution

  • 20192253046202 ()
  • 10192253046205 ()
  • 50192253046203 ()
5110

  • Skin cleaning wipe
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