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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 - 30014613333241

A549 PLATE W96/60F
DIAGNOSTIC HYBRIDS, INC.
56-9660
In Commercial Distribution

  • 30014613333241 ()
56-9660

  • Cell culture line IVD

Fresh Cells - 30014613333234

A549 CELLS MWP W96/32 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9632C
In Commercial Distribution

  • 30014613333234 ()
56-9632C

  • Cell culture line IVD

Fresh Cells - 30014613333227

A549 CELLS MWP W96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9624C
In Commercial Distribution

  • 30014613333227 ()
56-9624C

  • Cell culture line IVD

Fresh Cells - 30014613333210

A549 PLATE W48/48F
DIAGNOSTIC HYBRIDS, INC.
56-4848
In Commercial Distribution

  • 30014613333210 ()
56-4848

  • Cell culture line IVD

Fresh Cells - 30014613333203

A549 W48/24
DIAGNOSTIC HYBRIDS, INC.
56-4824
In Commercial Distribution

  • 30014613333203 ()
56-4824

  • Cell culture line IVD

Fresh Cells - 30014613333197

A549 W48/12
DIAGNOSTIC HYBRIDS, INC.
56-4812
In Commercial Distribution

  • 30014613333197 ()
56-4812

  • Cell culture line IVD

Fresh Cells - 30014613333180

A549 W24/24
DIAGNOSTIC HYBRIDS, INC.
56-2424
In Commercial Distribution

  • 30014613333180 ()
56-2424

  • Cell culture line IVD

Fresh Cells - 30014613333173

A549 W24/18
DIAGNOSTIC HYBRIDS, INC.
56-2418
In Commercial Distribution

  • 30014613333173 ()
56-2418

  • Cell culture line IVD

Fresh Cells - 30014613333166

A549 W24/12
DIAGNOSTIC HYBRIDS, INC.
56-2412
In Commercial Distribution

  • 30014613333166 ()
56-2412

  • Cell culture line IVD

Fresh Cells - 30014613333159

A549 W24/06
DIAGNOSTIC HYBRIDS, INC.
56-2406
In Commercial Distribution

  • 30014613333159 ()
56-2406

  • Cell culture line IVD

Fresh Cells - 30014613333142

A549 6 WELL 6 FILL PLATE
DIAGNOSTIC HYBRIDS, INC.
56-0606
In Commercial Distribution

  • 30014613333142 ()
56-0606

  • Cell culture line IVD

Fresh Cells - 30014613333135

A549 TUBE LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
56-0600L
In Commercial Distribution

  • 30014613333135 ()
56-0600L

  • Cell culture line IVD

Fresh Cells - 30014613333128

A549 TUBE
DIAGNOSTIC HYBRIDS, INC.
56-0600
In Commercial Distribution

  • 30014613333128 ()
56-0600

  • Cell culture line IVD

Fresh Cells - 30014613333111

A549 SV/CS
DIAGNOSTIC HYBRIDS, INC.
56-0102
In Commercial Distribution

  • 30014613333111 ()
56-0102

  • Cell culture line IVD

Fresh Cells - 30014613333104

A549 FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
56-00050
In Commercial Distribution

  • 30014613333104 ()
56-00050

  • Cell culture line IVD

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

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

E-Pacer - 00858101008292

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

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

DeRoyal - 00749756677776

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5165
In Commercial Distribution

  • 00749756677776 ()
M5165

  • Gait rehabilitation system harness

DeRoyal - 00749756113076

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167
In Commercial Distribution

  • 00749756113076 ()
M5167

  • Gait rehabilitation system harness

DeRoyal - 00749756113069

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-72
In Commercial Distribution

  • 50749756113064 ()
  • 00749756113069 ()
M5166-72

  • Gait rehabilitation system harness

DeRoyal - 00749756113052

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166
In Commercial Distribution

  • 50749756113057 ()
  • 00749756113052 ()
M5166

  • Gait rehabilitation system harness

DeRoyal - 00749756735209

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness

DeRoyal - 00749756678032

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164
In Commercial Distribution

  • 00749756678032 ()
M5164

  • Gait rehabilitation system harness

DeRoyal - 00749756242417

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M2616D72
In Commercial Distribution

  • 50749756242412 ()
  • 00749756242417 ()
M2616D72

  • Gait rehabilitation system harness

DeRoyal - 00749756237499

Adaptor For Valleylab Optimum
DEROYAL INDUSTRIES, INC.
88-000696
In Commercial Distribution

  • 50749756237494 ()
  • 00749756237499 ()
88-000696

  • Surgical plume evacuation system
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