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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MRHF FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T075
In Commercial Distribution

  • 30014613331827 ()
44-T075

  • Cell culture line IVD
MRHF FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T025
In Commercial Distribution

  • 30014613331810 ()
44-T025

  • Cell culture line IVD
MRHF PLATE W96 96F
DIAGNOSTIC HYBRIDS, INC.
44-9696
In Commercial Distribution

  • 30014613331803 ()
44-9696

  • Cell culture line IVD
MRHF PLATE W96 (EOC)
DIAGNOSTIC HYBRIDS, INC.
44-9648C
In Commercial Distribution

  • 30014613331797 ()
44-9648C

  • Cell culture line IVD
MRHF MW PLATE W96/12F
DIAGNOSTIC HYBRIDS, INC.
44-9612
In Commercial Distribution

  • 30014613331780 ()
44-9612

  • Cell culture line IVD
MRHF PLATE W24/24F
DIAGNOSTIC HYBRIDS, INC.
44-2424
In Commercial Distribution

  • 30014613331773 ()
44-2424

  • Cell culture line IVD
MRHF TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
44-0600
In Commercial Distribution

  • 30014613331766 ()
44-0600

  • Cell culture line IVD
MRHF SHELL VIAL W/CS
DIAGNOSTIC HYBRIDS, INC.
44-0102
In Commercial Distribution

  • 30014613331759 ()
44-0102

  • Cell culture line IVD
MRHF FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
44-00050
In Commercial Distribution

  • 30014613331742 ()
44-00050

  • Cell culture line IVD
HEL FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T150
In Commercial Distribution

  • 30014613331735 ()
43-T150

  • Cell culture line IVD
HEL FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T075
In Commercial Distribution

  • 30014613331728 ()
43-T075

  • Cell culture line IVD
HEL TUBE
DIAGNOSTIC HYBRIDS, INC.
43-0600
In Commercial Distribution

  • 30014613331711 ()
43-0600

  • Cell culture line IVD
NHFL 75 SQ CM LOW PASSAGE
DIAGNOSTIC HYBRIDS, INC.
42-T075C
In Commercial Distribution

  • 30014613331704 ()
42-T075C

  • Cell culture line IVD
NHFL 75 SQ CM FLK
DIAGNOSTIC HYBRIDS, INC.
42-T075
In Commercial Distribution

  • 30014613331698 ()
42-T075

  • Cell culture line IVD
RMK SV5/SV40 PLATE 24-WELL
DIAGNOSTIC HYBRIDS, INC.
18-309-24
In Commercial Distribution

  • 30014613331445 ()
18-309-24

  • Cell culture line IVD
RMK SV5/SV40 FLK/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-75
In Commercial Distribution

  • 30014613331438 ()
16-309-75

  • Cell culture line IVD
RMK SV5/SV40 FLK/150 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-150
In Commercial Distribution

  • 30014613331421 ()
16-309-150

  • Cell culture line IVD
RMK FLKS/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-308-75
In Commercial Distribution

  • 30014613331414 ()
16-308-75

  • Cell culture line IVD
RMK SV5/SV40 VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-309
In Commercial Distribution

  • 30014613331407 ()
15-309

  • Cell culture line IVD
PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD
RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD
RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP05X-000
In Commercial Distribution

  • 90841823103546 ()
  • 00841823103543 ()
FO06K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO05K-SP05X-000
In Commercial Distribution

  • 90841823103539 ()
  • 00841823103536 ()
FO05K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP26X-A00
In Commercial Distribution

  • 00841823103529 ()
FO04K-SP26X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP05X-000
In Commercial Distribution

  • 90841823103515 ()
  • 00841823103512 ()
FO04K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO03K-SP05X-000
In Commercial Distribution

  • 90841823103508 ()
  • 00841823103505 ()
FO03K-SP05X-000

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

  • 00817688021797 ()


  • Surgical plume evacuation system
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
922512FT
Not in Commercial Distribution

  • 05037881011103 ()

  • Dimension 25 x 120 mm
922512FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920611FT
Not in Commercial Distribution

  • 05037881011080 ()

  • Dimension 6 x 110 mm
920611FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921550FT
Not in Commercial Distribution

  • 05037881011066 ()

  • Dimension 15 x 50 mm
921550FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921010FT
Not in Commercial Distribution

  • 05037881011059 ()

  • Dimension 10 x 100 mm
921010FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921050FT
Not in Commercial Distribution

  • 05037881011035 ()

  • Dimension 10 x 50 mm
921050FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch VS125 TAPERED PATCH
VASCUTEK LTD
921020FTS
Not in Commercial Distribution

  • 05037881003238 ()

  • Dimension 10 x 200 mm
921020FTS

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921015FT
Not in Commercial Distribution

  • 05037881011097 ()

  • Dimension 10 x 150 mm
921015FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921575FT
Not in Commercial Distribution

  • 05037881011073 ()

  • Dimension 15 x 75 mm
921575FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921075FT
Not in Commercial Distribution

  • 05037881011042 ()

  • Dimension 10 x 75 mm
921075FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920875FT
Not in Commercial Distribution

  • 05037881011028 ()

  • Dimension 8 x 75 mm
920875FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920675FT
Not in Commercial Distribution

  • 05037881011011 ()

  • Dimension 6 x 75 mm
920675FT

  • Cardiovascular patch, animal-derived
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 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
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™ 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™ 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
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 TSH Linearity Kit
In Commercial Distribution

  • 08809317540559 ()
FLK-TSH

  • Non-blood cell primer/calibrator/control material IVD, reagent
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
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
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