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

Show Filters

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
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
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
FRENDâ„¢ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FRENDâ„¢ System. The Linearity Kit is for the FRENDâ„¢ System only. FRENDâ„¢ 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
FRENDâ„¢ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FRENDâ„¢ System. The Linearity kit is for the FRENDâ„¢ System only. FRENDâ„¢ 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
FRENDâ„¢ 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
FRENDâ„¢ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FRENDâ„¢ System. The Linearity Kit is for the FRENDâ„¢ System only. FRENDâ„¢ 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
FRENDâ„¢ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FRENDâ„¢ System. The Linearity Kit is for the FRENDâ„¢ System only. FRENDâ„¢ 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
FRENDâ„¢ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FRENDâ„¢ System. The Linearity Kit is for the FRENDâ„¢ System only. FRENDâ„¢ 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 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525422
In Commercial Distribution

  • 30845854061415 ()
57525422

  • Surgical plume evacuation system
FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525420
In Commercial Distribution

  • 30845854061408 ()
  • 10845854061404 ()
57525420

  • Surgical plume evacuation system
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)
No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system
MADIN-DARBY CANINE KIDNEY T150
DIAGNOSTIC HYBRIDS, INC.
99-84121903-T150
In Commercial Distribution

  • 30014613335511 ()
99-84121903-T150

  • Cell culture line IVD
MADIN-DARBY CANINE KIDNEY T75
DIAGNOSTIC HYBRIDS, INC.
99-84121903-T075
In Commercial Distribution

  • 30014613335504 ()
99-84121903-T075

  • Cell culture line IVD
MADIN-DARB CAN KIDNEY W96/96
DIAGNOSTIC HYBRIDS, INC.
99-84121903-9696
In Commercial Distribution

  • 30014613335498 ()
99-84121903-9696

  • Cell culture line IVD
MADIN-DARBYCANI KIDNEYW96/60
DIAGNOSTIC HYBRIDS, INC.
99-84121903-9660
In Commercial Distribution

  • 30014613335481 ()
99-84121903-9660

  • Cell culture line IVD
MADIN-DARBY CANI KIDW384/384
DIAGNOSTIC HYBRIDS, INC.
99-84121903-384384
In Commercial Distribution

  • 30014613335474 ()
99-84121903-384384

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

  • 30014613335429 ()
98-9696

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

  • 30014613335412 ()
98-9624C

  • Cell culture line IVD
H&V MIX CELLS MWP 96/12 CUST
DIAGNOSTIC HYBRIDS, INC.
98-9612C
In Commercial Distribution

  • 30014613335405 ()
98-9612C

  • Cell culture line IVD
H&V MIX CELLS MWP W48/36F
DIAGNOSTIC HYBRIDS, INC.
98-4836C
In Commercial Distribution

  • 30014613335399 ()
98-4836C

  • Cell culture line IVD
H&V MIX CELLS MWP W48/24F
DIAGNOSTIC HYBRIDS, INC.
98-4824
In Commercial Distribution

  • 30014613335382 ()
98-4824

  • Cell culture line IVD
H&V MIX CELLS MWP W48/18F
DIAGNOSTIC HYBRIDS, INC.
98-4818
In Commercial Distribution

  • 30014613335375 ()
98-4818

  • Cell culture line IVD
H&V-MIX MWP W48/12F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
98-4812C
In Commercial Distribution

  • 30014613335368 ()
98-4812C

  • Cell culture line IVD
H&V-MIX MWP W48/12F
DIAGNOSTIC HYBRIDS, INC.
98-4812
In Commercial Distribution

  • 30014613335351 ()
98-4812

  • Cell culture line IVD
H&V MIX CELLS MWP 48/08 FILL
DIAGNOSTIC HYBRIDS, INC.
98-4808DS
In Commercial Distribution

  • 30014613335344 ()
98-4808DS

  • Cell culture line IVD
H&V MIX W48/06 CUST FILL
DIAGNOSTIC HYBRIDS, INC.
98-4806C
In Commercial Distribution

  • 30014613335337 ()
98-4806C

  • Cell culture line IVD
H&V MIX W48/06
DIAGNOSTIC HYBRIDS, INC.
98-4806
In Commercial Distribution

  • 30014613335320 ()
98-4806

  • Cell culture line IVD
H&V-MIX MWP W24/24F
DIAGNOSTIC HYBRIDS, INC.
98-2424
In Commercial Distribution

  • 30014613335313 ()
98-2424

  • Cell culture line IVD
H&V-MIX MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
98-2418
In Commercial Distribution

  • 30014613335306 ()
98-2418

  • Cell culture line IVD
H&V-MIX MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
98-2412
In Commercial Distribution

  • 30014613335290 ()
98-2412

  • Cell culture line IVD
H&V-MIX MWP W24/09F
DIAGNOSTIC HYBRIDS, INC.
98-2409
In Commercial Distribution

  • 30014613335283 ()
98-2409

  • Cell culture line IVD
H&V-MIX MWP W24/06F
DIAGNOSTIC HYBRIDS, INC.
98-2406
In Commercial Distribution

  • 30014613335276 ()
98-2406

  • Cell culture line IVD
H&V MIX SV/CS
DIAGNOSTIC HYBRIDS, INC.
98-0102
In Commercial Distribution

  • 30014613335269 ()
98-0102

  • Cell culture line IVD
H&V MIX SV
DIAGNOSTIC HYBRIDS, INC.
98-0101
In Commercial Distribution

  • 30014613335252 ()
98-0101

  • Cell culture line IVD
R-MIX TOO MWP W96/96
DIAGNOSTIC HYBRIDS, INC.
97-9696
In Commercial Distribution

  • 30014613335245 ()
97-9696

  • Cell culture line IVD
R-MIX TOO MWP W96/60F
DIAGNOSTIC HYBRIDS, INC.
97-9660
In Commercial Distribution

  • 30014613335238 ()
97-9660

  • Cell culture line IVD
< 1 ... 5 6 7 8 9 ... 30 >