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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 - 30014613332329

MRC-5 W48/06
DIAGNOSTIC HYBRIDS, INC.
51-4806
In Commercial Distribution

  • 30014613332329 ()
51-4806

  • Cell culture line IVD

Fresh Cells - 30014613332312

MRC-5 W24/24
DIAGNOSTIC HYBRIDS, INC.
51-2424
In Commercial Distribution

  • 30014613332312 ()
51-2424

  • Cell culture line IVD

Fresh Cells - 30014613332305

MRC-5 W24/18
DIAGNOSTIC HYBRIDS, INC.
51-2418
In Commercial Distribution

  • 30014613332305 ()
51-2418

  • Cell culture line IVD

Fresh Cells - 30014613332299

MRC-5 W24/12
DIAGNOSTIC HYBRIDS, INC.
51-2412
In Commercial Distribution

  • 30014613332299 ()
51-2412

  • Cell culture line IVD

Fresh Cells - 30014613332282

MRC-5 W24/09
DIAGNOSTIC HYBRIDS, INC.
51-2409
In Commercial Distribution

  • 30014613332282 ()
51-2409

  • Cell culture line IVD

Fresh Cells - 30014613332275

MRC-5 W24/06
DIAGNOSTIC HYBRIDS, INC.
51-2406
In Commercial Distribution

  • 30014613332275 ()
51-2406

  • Cell culture line IVD

Fresh Cells - 30014613332268

MRC-5 CELLS TUBE CULT 13MM
DIAGNOSTIC HYBRIDS, INC.
51-0620EU
In Commercial Distribution

  • 30014613332268 ()
51-0620EU

  • Cell culture line IVD

Fresh Cells - 30014613332251

MRC-5 CELLS TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
51-0600
In Commercial Distribution

  • 30014613332251 ()
51-0600

  • Cell culture line IVD

Fresh Cells - 30014613332244

MRC-5 SV/CS
DIAGNOSTIC HYBRIDS, INC.
51-0102
In Commercial Distribution

  • 30014613332244 ()
51-0102

  • Cell culture line IVD

Fresh Cells - 30014613332237

MRC-5 SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
51-0101
In Commercial Distribution

  • 30014613332237 ()
51-0101

  • Cell culture line IVD

Fresh Cells - 30014613332220

MRC-5 FROZEN SUSP.
DIAGNOSTIC HYBRIDS, INC.
51-00125C
In Commercial Distribution

  • 30014613332220 ()
51-00125C

  • Cell culture line IVD

Fresh Cells - 30014613332213

MRC-5 FROZEN SUSP. 50-MER
DIAGNOSTIC HYBRIDS, INC.
51-00050
In Commercial Distribution

  • 30014613332213 ()
51-00050

  • Cell culture line IVD

Fresh Cells - 30014613332206

RHMK FLK 150 W/A
DIAGNOSTIC HYBRIDS, INC.
49-T150A
In Commercial Distribution

  • 30014613332206 ()
49-T150A

  • Cell culture line IVD

Fresh Cells - 30014613332190

RHMK FLK 150
DIAGNOSTIC HYBRIDS, INC.
49-T150
In Commercial Distribution

  • 30014613332190 ()
49-T150

  • Cell culture line IVD

Fresh Cells - 30014613332183

RHMK FLK 75 W/A
DIAGNOSTIC HYBRIDS, INC.
49-T075A
In Commercial Distribution

  • 30014613332183 ()
49-T075A

  • Cell culture line IVD

Fresh Cells - 30014613331421

RMK SV5/SV40 FLK/150 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-150
In Commercial Distribution

  • 30014613331421 ()
16-309-150

  • Cell culture line IVD

Fresh Cells - 30014613331414

RMK FLKS/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-308-75
In Commercial Distribution

  • 30014613331414 ()
16-308-75

  • Cell culture line IVD

Fresh Cells - 30014613331407

RMK SV5/SV40 VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-309
In Commercial Distribution

  • 30014613331407 ()
15-309

  • Cell culture line IVD

Fresh Cells - 30014613331391

PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD

Fresh Cells - 30014613331384

RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD

Fresh Cells - 30014613331377

RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD

Fresh Cells - 30014613339571

Hela, MWP, 96W24F
DIAGNOSTIC HYBRIDS, INC.
72-9624C
In Commercial Distribution

  • 30014613339571 ()
72-9624C

  • Cell culture line IVD

Fresh Cells - 30014613339564

VERO SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
84-0101
In Commercial Distribution

  • 30014613339564 ()
84-0101

  • Cell culture line IVD

Fresh Cells - 30014613339281

Vero E6, MWP, 96W96F 90% conf
DIAGNOSTIC HYBRIDS, INC.
50-91-9696-90
In Commercial Distribution

  • 30014613339281 ()
50-91-9696-90

  • Cell culture line IVD

Fresh Cells - 30014613339274

Vero E6, MWP, 96W96F
DIAGNOSTIC HYBRIDS, INC.
91-9696
In Commercial Distribution

  • 30014613339274 ()
91-9696

  • Cell culture line IVD

Fresh Cells - 30014613338420

Super-BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
70-T225
In Commercial Distribution

  • 30014613338420 ()
70-T225

  • Cell culture line IVD

Fresh Cells - 30014613338413

BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T225
In Commercial Distribution

  • 30014613338413 ()
53-T225

  • Cell culture line IVD

Fresh Cells - 30014613338307

RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613338260

MDCK FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
83-T225DH
In Commercial Distribution

  • 30014613338260 ()
83-T225DH

  • Cell culture line IVD

Fresh Cells - 30014613335627

CITES RHMK FLK
DIAGNOSTIC HYBRIDS, INC.
C49-T150A
In Commercial Distribution

  • 30014613335627 ()
C49-T150A

  • Cell culture line IVD

Fresh Cells - 30014613335610

CITES KIDNEY RHESUS TUBE W/A
DIAGNOSTIC HYBRIDS, INC.
C49-0600A
In Commercial Distribution

  • 30014613335610 ()
C49-0600A

  • Cell culture line IVD

Fresh Cells - 30014613335603

CITES KIDNEY RHESUS SV W/C AN
DIAGNOSTIC HYBRIDS, INC.
C49-0102A
In Commercial Distribution

  • 30014613335603 ()
C49-0102A

  • Cell culture line IVD

Fresh Cells - 30014613335597

RHMK P1 FROZEN SUSP. CITES
DIAGNOSTIC HYBRIDS, INC.
C49-00010P
In Commercial Distribution

  • 30014613335597 ()
C49-00010P

  • Cell culture line IVD

Foot Switch - 00817688021797

No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • 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)

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

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

Extended-Life Battery - 3 Pack - 00852184003380

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

  • 00852184003380 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

EvacuCart - 00851136002396

Portable Cart for Smoke Evacuators
Buffalo Filter
ETC01
Not in Commercial Distribution

  • 00851136002396 ()


  • Surgical plume evacuation system

Electrode Delivery Tool Kit, MedCoat, HDE - 00852184003465

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003465 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Electrode Delivery Tool Kit MedCoat, CE - 00852184003373

No Description
Synapse Biomedical, Inc.
22-0018
In Commercial Distribution

  • 00852184003373 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

EasyVac - 30845854081017

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

ESU Sensor - 00817688021742

No Description
I.C. MEDICAL, INC.
2250
Not in Commercial Distribution

  • 00817688021742 ()
ICM-000-0422

  • Surgical plume evacuation system

ESU Sensor - 00817688021711

No Description
I.C. MEDICAL, INC.
ICM-000-0009
In Commercial Distribution

  • 00817688021711 ()


  • Surgical plume evacuation system
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