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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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Kit Urine Collection for South Shore Hospital Only
AERO-MED, LLC
CA56125
In Commercial Distribution

  • 50885380200241 ()
  • 10885380200243 ()
CA56125

  • Urine specimen collection kit IVD
*CUSTOM* South Metro IV Admin 10 drop kit
BOUND TREE MEDICAL, LLC
8600-01354
In Commercial Distribution

  • 00812277033069 ()
8600-01354

  • Peripheral vascular intervention infusion catheter
Pack Vein F/ Cardiovascular Specialists of South Florida
HENRY SCHEIN, INC.
5703723
In Commercial Distribution

  • 00304040180464 ()
  • 10304040180461 ()
5703723

  • General surgical procedure kit, non-medicated, single-use
10M - State of South Dakota DOT BBP - Metal
Certified Safety Manufacturing, Inc.
FK412-001
In Commercial Distribution

  • 00766588120010 ()
FK412-001

  • Cardiopulmonary resuscitation mask, single-use
  • First aid kit, medicated
  • Non-rebreathing valve, single-use
PlasmaJet Ultra Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-3130IS-ZA
In Commercial Distribution

  • M397PS103130ISZA0 ()
PS10-3130IS-ZA

  • Plasma surgical system
PlasmaJet V3 Plus Console System In-Service (South Africa)
PLASMA SURGICAL, INC
PS10-2130IS-ZA
In Commercial Distribution

  • M397PS102130ISZA0 ()
PS10-2130IS-ZA

  • Plasma surgical system
Kit Contains: CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFF73, 12x100 Kii® Fios® ADVFIX 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
K2749
In Commercial Distribution

  • 30607915134212 ()


  • Tissue extraction bag
  • Laparoscopic access cannula, single-use
  • Ligation clip, metallic
Oxidant Reagent (CC445)
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC445
In Commercial Distribution

  • 00817302024678 ()

  • Total Volume: 500 Milliliter
  • Kit contains 2 R1 bottles
CC445

  • Drug/toxicology adulteration IVD, kit, spectrophotometry
Aldolase Controls
CAROLINA LIQUID CHEMISTRIES CORPORATION
COAL-015
In Commercial Distribution

  • 00817302024661 ()

  • Total Volume: 2 Milliliter
  • Kit contains 2 R1 bottles and 2 R2 bottles
COAL-015

  • Aldolase IVD, control
Aldolase
CAROLINA LIQUID CHEMISTRIES CORPORATION
CALD-015
In Commercial Distribution

  • 00817302024654 ()

  • Total Volume: 15 Milliliter
  • Kit contains 10 R1 bottles
CALD-015

  • Aldolase IVD, reagent
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