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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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Fructosamine - 00811727013521

This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
12-F7546-55
In Commercial Distribution

  • 00811727013521 ()
12-F7546-55

  • Fructosamine IVD, kit, spectrophotometry

Pointe Scientific, Inc. - 00811727013354

Myoglobin for the quantitative determination of Myoglobin concentration in human serum. For in vitro diagnostic use only. 96 Tests.
POINTE SCIENTIFIC, INC.
CM1117-96
In Commercial Distribution

  • 00811727013354 ()
CM1117-96

  • Myoglobin IVD, kit, enzyme immunoassay (EIA)

POINTE SCIENTIFIC Fructosamine - 00811727011077

This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
F7546-110
In Commercial Distribution

  • 00811727011077 ()
F7546-110

  • Fructosamine IVD, kit, spectrophotometry

HALYARD - 16931918158495

BASICS* Femoral Angiography Drape with Dual Windows 88.5 in. x 115 in./225 cm x 292 cm - Handi-Bin_Non-Sterile_200EA/CS
GRI Medical & Electronic Technology Co., Ltd.
49867
In Commercial Distribution

  • 06931918158498 ()
  • 16931918158495 ()


  • Patient surgical drape, single-use

Halyard - 30680651314476

PICC Drape with Side Perforations, Full Body, Dual Fenestration, 110 in. x 78 in. / 279 cm x 198 cm
O&M HALYARD, INC.
31447
In Commercial Distribution

  • 90680651314478 ()
  • 30680651314476 ()
31447NS

  • Patient surgical drape, single-use, non-sterile

Halyard - 30680651314452

CVC Drape with Top Perforation, Full Body, Single Fenestration, 110 in. x 68 in. / 279 cm x 172 cm
O&M HALYARD, INC.
31445
In Commercial Distribution

  • 90680651314454 ()
  • 30680651314452 ()
31445NS

  • Patient surgical drape, single-use, non-sterile

HALYARD - 16931918132235

BASICS* Extra-Long Femoral Angiography Drape with Single Window, 82 in. x 135 in. / 208 cm x 343 cm_Non-Sterile_16EA/CS
GRI Medical & Electronic Technology Co., Ltd.
49871
In Commercial Distribution

  • 06931918132238 ()
  • 16931918132235 ()


  • Patient surgical drape, single-use

Symmetry QUAD-LOCK™ - 00887482021262

Quadlock® Bar, Spacer Polymer, Use With 50-9031 And 50-9032, Size 1 1/2 in x 5/8 in
SYMMETRY SURGICAL INC.
50-9030
Not in Commercial Distribution

  • 00887482021262 ()
50-9030

  • Device sterilization/disinfection container, reusable

neuro|mate® - Registration tool-holder - 03662724000093

The registration tool-holder (or ultrasound tool-holder) is used during registration in ultrasound Frameless mode. Delivered in a storage case.
RENISHAW MAYFIELD
Tool-holder
Not in Commercial Distribution

  • 03662724000093 ()
001.0106

  • Neurological stereotactic surgery system

Ferritin ELISA - B24225FERHUE010

This Ferritin ELISA is intended for use in the quantitative determination of ferritin in human serum. The assay is to be used in the diagnosis of diseases affecting iron metabolism.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
25-FERHU-E01
Not in Commercial Distribution

  • B24225FERHUE010 ()
25-FERHU-E01

  • Ferritin IVD, kit, enzyme immunoassay (EIA)
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