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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ELVIS MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
55-2412
In Commercial Distribution

  • 30014613333043 ()
55-2412

  • Cell culture line IVD
ELVIS MWP W24/10F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2410S
In Commercial Distribution

  • 30014613333036 ()
55-2410S

  • Cell culture line IVD
ELVIS MWP W24/9F
DIAGNOSTIC HYBRIDS, INC.
55-2409
In Commercial Distribution

  • 30014613333029 ()
55-2409

  • Cell culture line IVD
ELVIS MWP W24/8F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2408DF
In Commercial Distribution

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD
ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

  • Cell culture line IVD
ELVIS MWP W24/6F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2406S
In Commercial Distribution

  • 30014613332992 ()
55-2406S

  • Cell culture line IVD
ELVIS MWP W24/6F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2406DE
In Commercial Distribution

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD
ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD
ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD
ELVIS SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
55-0101
In Commercial Distribution

  • 30014613332954 ()
55-0101

  • Cell culture line IVD
No Description
I.C. MEDICAL, INC.
2250
Not in Commercial Distribution

  • 00817688021742 ()
ICM-000-0422

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0009
In Commercial Distribution

  • 00817688021711 ()


  • Surgical plume evacuation system
EasyVac Kit (1) EASYVAC 120V, (1) VSTR08, (1) EZLINK01, (1) FS10004, (3) S-PA2010, (2) BLAP100V, (3) S-VTWT624
Conmed Corporation
EASYVACKIT
In Commercial Distribution

  • 30845854081017 ()
EASYVACKIT

  • Surgical plume evacuation system
No Description
Synapse Biomedical, Inc.
22-0018
In Commercial Distribution

  • 00852184003373 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003465 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
Portable Cart for Smoke Evacuators
Buffalo Filter
ETC01
Not in Commercial Distribution

  • 00851136002396 ()


  • Surgical plume evacuation system
No Description
Synapse Biomedical, Inc.
22-0020
In Commercial Distribution

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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™ 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™ 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
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