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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

Fresh Cells - 30014613332893

MCCOY W48/24
DIAGNOSTIC HYBRIDS, INC.
54-4824
In Commercial Distribution

  • 30014613332893 ()
54-4824

  • Cell culture line IVD

Fresh Cells - 30014613332886

MCCOY W48/18
DIAGNOSTIC HYBRIDS, INC.
54-4818
In Commercial Distribution

  • 30014613332886 ()
54-4818

  • Cell culture line IVD

Fresh Cells - 30014613332879

MCCOY W48/12
DIAGNOSTIC HYBRIDS, INC.
54-4812
In Commercial Distribution

  • 30014613332879 ()
54-4812

  • Cell culture line IVD

Fresh Cells - 30014613332862

MCCOY W48/06
DIAGNOSTIC HYBRIDS, INC.
54-4806
In Commercial Distribution

  • 30014613332862 ()
54-4806

  • Cell culture line IVD

Fresh Cells - 30014613332855

MCCOY W24/24 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2424S
In Commercial Distribution

  • 30014613332855 ()
54-2424S

  • Cell culture line IVD

Fresh Cells - 30014613332848

MCCOY W24/24
DIAGNOSTIC HYBRIDS, INC.
54-2424
In Commercial Distribution

  • 30014613332848 ()
54-2424

  • Cell culture line IVD

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

Fresh Cells - 30014613332695

BGMK W96/60
DIAGNOSTIC HYBRIDS, INC.
53-9660
In Commercial Distribution

  • 30014613332695 ()
53-9660

  • Cell culture line IVD

Fresh Cells - 30014613332688

BGMK CELLS MWP W96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
53-9624C
In Commercial Distribution

  • 30014613332688 ()
53-9624C

  • Cell culture line IVD

Fresh Cells - 30014613332671

BGMK W48/24
DIAGNOSTIC HYBRIDS, INC.
53-4824
In Commercial Distribution

  • 30014613332671 ()
53-4824

  • Cell culture line IVD

Fresh Cells - 30014613332664

BGMK W48/18
DIAGNOSTIC HYBRIDS, INC.
53-4818
In Commercial Distribution

  • 30014613332664 ()
53-4818

  • Cell culture line IVD

Fresh Cells - 30014613332657

BGMK W48/12
DIAGNOSTIC HYBRIDS, INC.
53-4812
In Commercial Distribution

  • 30014613332657 ()
53-4812

  • Cell culture line IVD

Fresh Cells - 30014613332640

BGMK W48/06
DIAGNOSTIC HYBRIDS, INC.
53-4806
In Commercial Distribution

  • 30014613332640 ()
53-4806

  • Cell culture line IVD

Fresh Cells - 30014613332633

BGMK W24/24F
DIAGNOSTIC HYBRIDS, INC.
53-2424
In Commercial Distribution

  • 30014613332633 ()
53-2424

  • Cell culture line IVD

Fresh Cells - 30014613332626

BGMK W24/18
DIAGNOSTIC HYBRIDS, INC.
53-2418
In Commercial Distribution

  • 30014613332626 ()
53-2418

  • Cell culture line IVD

Fresh Cells - 30014613332619

BGMK W24/12
DIAGNOSTIC HYBRIDS, INC.
53-2412
In Commercial Distribution

  • 30014613332619 ()
53-2412

  • Cell culture line IVD

Fresh Cells - 30014613332602

BGMK W24/09
DIAGNOSTIC HYBRIDS, INC.
53-2409
In Commercial Distribution

  • 30014613332602 ()
53-2409

  • Cell culture line IVD

Fresh Cells - 30014613332596

BGMK W24/06
DIAGNOSTIC HYBRIDS, INC.
53-2406
In Commercial Distribution

  • 30014613332596 ()
53-2406

  • Cell culture line IVD

Fresh Cells - 30014613332589

BGMK TUBE
DIAGNOSTIC HYBRIDS, INC.
53-0600
In Commercial Distribution

  • 30014613332589 ()
53-0600

  • Cell culture line IVD

Fresh Cells - 30014613332572

BGMK SV/CS
DIAGNOSTIC HYBRIDS, INC.
53-0102
In Commercial Distribution

  • 30014613332572 ()
53-0102

  • Cell culture line IVD

Fresh Cells - 30014613332565

BGMK FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
53-00050
In Commercial Distribution

  • 30014613332565 ()
53-00050

  • Cell culture line IVD

Fresh Cells - 30014613332558

CV1 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
52-T150
In Commercial Distribution

  • 30014613332558 ()
52-T150

  • Cell culture line IVD

Fresh Cells - 30014613332541

CV1 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
52-T075
In Commercial Distribution

  • 30014613332541 ()
52-T075

  • Cell culture line IVD

Fresh Cells - 30014613332534

CV1 W24/24
DIAGNOSTIC HYBRIDS, INC.
52-2424
In Commercial Distribution

  • 30014613332534 ()
52-2424

  • Cell culture line IVD

Fresh Cells - 30014613332527

CV1 6 WELL 6 FILL
DIAGNOSTIC HYBRIDS, INC.
52-0606
In Commercial Distribution

  • 30014613332527 ()
52-0606

  • Cell culture line IVD

Fresh Cells - 30014613332510

CV1 GRT
DIAGNOSTIC HYBRIDS, INC.
52-0600
In Commercial Distribution

  • 30014613332510 ()
52-0600

  • Cell culture line IVD

Fresh Cells - 30014613332503

CV1 SV/CS
DIAGNOSTIC HYBRIDS, INC.
52-0102
In Commercial Distribution

  • 30014613332503 ()
52-0102

  • Cell culture line IVD
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