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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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DeRoyal - 00749756783286

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y
In Commercial Distribution

  • 00749756783286 ()
M5166Y

  • Gait rehabilitation system harness

DeRoyal - 00749756782616

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166Y-72
In Commercial Distribution

  • 00749756782616 ()
M5166Y-72

  • Gait rehabilitation system harness

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

E.M Adams co, inc. - 18100013407427

BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307427

BELT
E.M. ADAMS, INC.
EP26-63391-1
In Commercial Distribution

  • 50840200307418 ()
  • 10840200307427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307403

BELT
E.M. ADAMS, INC.
EP26-63375-1
In Commercial Distribution

  • 50840200307395 ()
  • 10840200307403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
In Commercial Distribution

  • 50840200307371 ()
  • 10840200307380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307366

BELT
E.M. ADAMS, INC.
EP26-63350-1
In Commercial Distribution

  • 50840200307357 ()
  • 10840200307366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 10840200307342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
In Commercial Distribution

  • 50840200307333 ()
  • 10840200307342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

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

FREND - 08809317540559

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 TSH Linearity Kit
In Commercial Distribution

  • 08809317540559 ()
FLK-TSH

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

FREND - 08809317540542

FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Testosterone 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 Testosterone Linearity Kit
In Commercial Distribution

  • 08809317540542 ()
FLK-TES

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

FREND - 08809317540535

FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only. FREND™ PSA Plus 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 PSA Plus Linearity Kit
In Commercial Distribution

  • 08809317540535 ()
FLK-PSA

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

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

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
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