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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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CONTOUR® NEXT - 10301937278706

Blood Glucose Test Strips - 35 Test Strips (per bottle) - sold in a carton of 2 bottles (70 test strips total).
ASCENSIA DIABETES CARE US INC.
7278
In Commercial Distribution

  • 40301937278707 ()
  • 00301937278709 ()
  • 10301937278706 ()
  • 00301937278013 ()
85701231

  • Glucose monitoring system IVD, home-use

X SERIES - 00812394026098

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221011-01-662
In Commercial Distribution

  • 00812394026098 ()


  • Rechargeable professional automated external defibrillator

BD SurePath™ Manual Method Kit - 00382904912666

BD SurePath™ Manual Method Kit: BD SurePath™ PreCoat slides (5 X 96) & BD Settling Chambers (2 X 240)
BECTON, DICKINSON AND COMPANY
491266
In Commercial Distribution

  • 00382904912666 ()
491266

  • Endocervical specimen cytological examination kit IVD

TRUFILL - 10886704085324

TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels
Cerenovus, Inc.
632400NA
In Commercial Distribution

  • 10886704085324 ()
632400NA

  • Neurovascular embolization plug

ORAPLUG® - 10381780000327

SALVIN OraPLUG® Absorbable Collagen Wound Dressing, 3/8in x 3/4in
Integra Lifesciences Corporation
#ORAPLUG-PKG-10
Not in Commercial Distribution

  • 30381780000321 ()
  • 10381780000327 ()
  • M268ORAPLUGPKG101 ()
  • 00381780000320 ()

  • 1 cm x 2 cm
  • 3/8 in x 3/4 in
#ORAPLUG-PKG-10

  • General oral wound dressing, animal-derived

Integra® Miltex® HeliTape® - 10381780000303

HeliPlug ® ABSORBABLE COLLAGEN Wound Dressing, 3/8in x 3/4in
Integra Lifesciences Corporation
62202
In Commercial Distribution

  • 30381780000307 ()
  • 10381780000303 ()
  • H834622021 ()
  • 00381780000306 ()

  • 1 cm x 2 cm
  • 3/8 in x 3/4 in
62-202

  • General oral wound dressing, animal-derived

CollaPlug® - 10381780000259

CollaPlug® Absorbable Collagen Wound Dressing, 3/8in x 3/4in
Integra Lifesciences Corporation
0102
In Commercial Distribution

  • 30381780000253 ()
  • 10381780000259 ()
  • H13301021 ()
  • 00381780000252 ()

  • 1 cm x 2 cm
  • 3/8 in X 3/4 in
0102

  • General oral wound dressing, animal-derived

creos™ - 10381780490036

creos™ xenoplug Absorbable Collagen Wound Dressing for Dental Surgery
Integra Lifesciences Corporation
WD62202
In Commercial Distribution

  • 30381780490016 ()
  • 10381780490036 ()
  • 00381780490039 ()

  • 3/8 in x 3/4 in
  • 1 cm x 2 cm
WD62202

  • General oral wound dressing, animal-derived

Powerheart® G3 TSO Battery - 00812394020898

IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C142A certified with 2 year full replacement guarantee.
Zoll Medical Corporation
9147-201-TSO
In Commercial Distribution

9147-201-TSO

  • Primary battery

Powerheart® G3 TSO Battery - 00812394020300

IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C142A certified with 2 year full replacement guarantee.
Cardiac Science Corporation
9147-201-TSO
In Commercial Distribution

  • 00812394020300 ()
9147-201-TSO

  • Primary battery
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