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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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Fresh Cells - 30014613332831

MCCOY W24/18
DIAGNOSTIC HYBRIDS, INC.
54-2418
In Commercial Distribution

  • 30014613332831 ()
54-2418

  • Cell culture line IVD

Fresh Cells - 30014613332824

MCCOY W24/12 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2412S
In Commercial Distribution

  • 30014613332824 ()
54-2412S

  • Cell culture line IVD

Fresh Cells - 30014613332817

MCCOY W24/12
DIAGNOSTIC HYBRIDS, INC.
54-2412
In Commercial Distribution

  • 30014613332817 ()
54-2412

  • Cell culture line IVD

Fresh Cells - 30014613332800

MCCOY PLATES
DIAGNOSTIC HYBRIDS, INC.
54-2406
In Commercial Distribution

  • 30014613332800 ()
54-2406

  • Cell culture line IVD

Fresh Cells - 30014613332794

MCCOY SV/CS WITH LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
54-0102L
In Commercial Distribution

  • 30014613332794 ()
54-0102L

  • Cell culture line IVD

Fresh Cells - 30014613332787

MCCOY SV/CS
DIAGNOSTIC HYBRIDS, INC.
54-0102
In Commercial Distribution

  • 30014613332787 ()
54-0102

  • Cell culture line IVD

Fresh Cells - 30014613332770

MCCOY FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
54-00050C
In Commercial Distribution

  • 30014613332770 ()
54-00050C

  • Cell culture line IVD

Fresh Cells - 30014613332763

MCCOY FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
54-00050
In Commercial Distribution

  • 30014613332763 ()
54-00050

  • Cell culture line IVD

Fresh Cells - 30014613332756

BGMK FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T150
In Commercial Distribution

  • 30014613332756 ()
53-T150

  • Cell culture line IVD

Fresh Cells - 30014613332749

BGMK FLK 75 SQ CM LIGHT
DIAGNOSTIC HYBRIDS, INC.
53-T075C
In Commercial Distribution

  • 30014613332749 ()
53-T075C

  • Cell culture line IVD

Fresh Cells - 30014613332732

BGMK FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T075
In Commercial Distribution

  • 30014613332732 ()
53-T075

  • Cell culture line IVD

Fresh Cells - 30014613332725

BGMK FLASK 25 SQ CM 50% CONFLU
DIAGNOSTIC HYBRIDS, INC.
53-T025-50
In Commercial Distribution

  • 30014613332725 ()
53-T025-50

  • Cell culture line IVD

Fresh Cells - 30014613332718

BGMK FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T025
In Commercial Distribution

  • 30014613332718 ()
53-T025

  • Cell culture line IVD

Fresh Cells - 30014613332701

BGMK W96/96
DIAGNOSTIC HYBRIDS, INC.
53-9696
In Commercial Distribution

  • 30014613332701 ()
53-9696

  • Cell culture line IVD

Foot Switch - 00817688021797

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

  • 00817688021797 ()


  • 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)

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

FREND - 08809317540825

FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD

FREND - 08809317540566

FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH 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 Vitamin D Linearity Kit
In Commercial Distribution

  • 08809317540566 ()
FLK-VTD

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