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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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Extended-Life Battery - 3 Pack - 00852184003380

No Description
Synapse Biomedical, Inc.
22-0020
In Commercial Distribution

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

FILTRESSE - H671SSE2000

Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system

FILTRESSE - H671SSE1000

Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system

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 - 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 - 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 - 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 - 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 - 30014613335511

MADIN-DARBY CANINE KIDNEY T150
DIAGNOSTIC HYBRIDS, INC.
99-84121903-T150
In Commercial Distribution

  • 30014613335511 ()
99-84121903-T150

  • Cell culture line IVD

Fresh Cells - 30014613335504

MADIN-DARBY CANINE KIDNEY T75
DIAGNOSTIC HYBRIDS, INC.
99-84121903-T075
In Commercial Distribution

  • 30014613335504 ()
99-84121903-T075

  • Cell culture line IVD

Fresh Cells - 30014613335498

MADIN-DARB CAN KIDNEY W96/96
DIAGNOSTIC HYBRIDS, INC.
99-84121903-9696
In Commercial Distribution

  • 30014613335498 ()
99-84121903-9696

  • Cell culture line IVD

Fresh Cells - 30014613335481

MADIN-DARBYCANI KIDNEYW96/60
DIAGNOSTIC HYBRIDS, INC.
99-84121903-9660
In Commercial Distribution

  • 30014613335481 ()
99-84121903-9660

  • Cell culture line IVD

Fresh Cells - 30014613335474

MADIN-DARBY CANI KIDW384/384
DIAGNOSTIC HYBRIDS, INC.
99-84121903-384384
In Commercial Distribution

  • 30014613335474 ()
99-84121903-384384

  • Cell culture line IVD

Fresh Cells - 30014613335429

H&V MIX CELLS MWP 96/96 FILL
DIAGNOSTIC HYBRIDS, INC.
98-9696
In Commercial Distribution

  • 30014613335429 ()
98-9696

  • Cell culture line IVD

Fresh Cells - 30014613335412

H&V MIX CELLS MWP 96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
98-9624C
In Commercial Distribution

  • 30014613335412 ()
98-9624C

  • Cell culture line IVD
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