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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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Curaplex® - 00810094578176

Curaplex Epi Kit (.5mL Luer Lock Syringe, 21Ga x 1in Hypodermic Needle, Epinephrine 1mg, 1ml vial)
BOUND TREE MEDICAL, LLC
SRXEPI-24-KIT
In Commercial Distribution

  • 00810094579289 ()
  • 00810094578176 ()
SRXEPI-24-KIT

  • First aid kit, medicated

REC Class B 21 - 36 Metal - 00766588251004

REC Class B 21 - 36 Metal
Certified Safety Manufacturing, Inc.
K625-100
In Commercial Distribution

  • 00766588251004 ()
K625-100

  • First aid kit, medicated

DC Safety - 00816058013127

FAK
DC Safety Sales
PT420-76110
In Commercial Distribution

  • 10816058013124 ()
  • 00816058013127 ()
  • 30816058013128 ()
PT420-76110

  • Medical bag

DC Safety - 00816058013110

RAK
DC Safety Sales
C9N1W3800
In Commercial Distribution

  • 10816058013117 ()
  • 00816058013110 ()
  • 30816058013111 ()
C9N1W3800

  • Medical bag

SPLINTER OUT - 00098108000039

No Description
MediPoint Holdings LLC
Splinter Out Kit - 28
In Commercial Distribution

  • 00098108000039 ()


  • First aid kit, medicated

NAR - 00842209135745

No Description
NORTH AMERICAN RESCUE, LLC
85-4547
In Commercial Distribution

  • 00842209135745 ()
85-4547

  • First aid kit, medicated

NAR - 00842209135738

No Description
NORTH AMERICAN RESCUE, LLC
82-0085
In Commercial Distribution

  • 00842209135738 ()
82-0085

  • First aid kit, medicated

NAR - 00842209135721

No Description
NORTH AMERICAN RESCUE, LLC
82-0084
In Commercial Distribution

  • 00842209135721 ()
82-0084

  • First aid kit, medicated

BinaxNOW COVID-19 Reagent Accessory Kit - 00811877011576

Reagent Accessory Pack intended for use only with BinaxNOW™ COVID-19 product.
Alere Scarborough, Inc.
195-090
In Commercial Distribution

  • 00811877011576 ()


  • SARS-CoV-2 antigen IVD, reagent

ZGO Guided Key for ZT2030 and ZT2535 - 00850017652774

ZGO Guided Keys provide drilling control of the osteotomy. The ZGO Key can be used with printed guides with C-Guide Sleeves to control the angulation of the osteotomy.
VERSAH, LLC
ZGK-L
In Commercial Distribution

  • 00850017652774 ()


  • Surgical instrument interim-placement holder, reusable
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