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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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FREND - 08809317540528

FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Free T4 Linearity Kit
In Commercial Distribution

  • 08809317540528 ()
FLK-FT4

  • Non-blood cell primer/calibrator/control material IVD, reagent

FUMOVAC - 30845854061415

FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525422
In Commercial Distribution

  • 30845854061415 ()
57525422

  • Surgical plume evacuation system

FUMOVAC - 30845854061408

FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525420
In Commercial Distribution

  • 30845854061408 ()
  • 10845854061404 ()
57525420

  • Surgical plume evacuation system

FilmArray® Respiratory Panel (RP) EZ - 00815381020147

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Foot Switch - 00817688021797

No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system

Fresh Cells - 30014613332947

MCCOY FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
54-T150
In Commercial Distribution

  • 30014613332947 ()
54-T150

  • Cell culture line IVD

Fresh Cells - 30014613332930

MCCOY FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
54-T075
In Commercial Distribution

  • 30014613332930 ()
54-T075

  • Cell culture line IVD

Fresh Cells - 30014613332923

MCCOY W96/96
DIAGNOSTIC HYBRIDS, INC.
54-9696
In Commercial Distribution

  • 30014613332923 ()
54-9696

  • Cell culture line IVD

Fresh Cells - 30014613332916

MCCOY W48/48
DIAGNOSTIC HYBRIDS, INC.
54-4848
In Commercial Distribution

  • 30014613332916 ()
54-4848

  • Cell culture line IVD

Fresh Cells - 30014613332909

MCCOY W48/36
DIAGNOSTIC HYBRIDS, INC.
54-4836C
In Commercial Distribution

  • 30014613332909 ()
54-4836C

  • Cell culture line IVD
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