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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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Timex - 00715317196215

5:20 Pm Gunmetal Spectacle
Kenmark Optical, Inc.
520PGM60
In Commercial Distribution

  • 00715317196215 ()


  • Prescription spectacles

Timex - 00715317196208

5:20 Pm Gunmetal Spectacle
Kenmark Optical, Inc.
520PGM58
In Commercial Distribution

  • 00715317196208 ()


  • Prescription spectacles

Timex - 00715317196192

5:20 Pm Gunmetal Spectacle
Kenmark Optical, Inc.
520PGM56
In Commercial Distribution

  • 00715317196192 ()


  • Prescription spectacles

TrinityBiotech - 05391516746342

Uni-Gold™ Cryptosporidium, 20 Tests
MARDX DIAGNOSTICS, INC.
1206620
In Commercial Distribution

  • 05391516746342 ()
1206620

  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

Trinity Biotech - 05391516746328

Uni-Gold™ Giardia, 20 Tests
MARDX DIAGNOSTICS, INC.
1206610
In Commercial Distribution

  • 05391516746328 ()
1206610

  • Giardia lamblia immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516741552

Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests)
TRINITY BIOTECH PUBLIC LIMITED COMPANY
345-A
In Commercial Distribution

  • 05391516741552 ()

  • 20 Tests
345-A

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry

SpineJet® - 00853235007173

SpineJet® 20° XL MIS-Rectangle
HYDROCISION, INC.
58662
In Commercial Distribution

  • 00853235007173 ()
58662

  • Water jet knife system handpiece, single-use

SpineJet® - 00853235007159

SpineJet® 20° XL MIS-Oval
HYDROCISION, INC.
58162
In Commercial Distribution

  • 00853235007159 ()
58162

  • Water jet knife system handpiece, single-use

SpineJet® - 00853235007135

SpineJet® 20 XLS Rectangle
HYDROCISION, INC.
57662
In Commercial Distribution

  • 00853235007135 ()
57662

  • Water jet knife system handpiece, single-use

Elite - 00643293026762

Elite Trendelenburg System 20 Degrees
TRULIFE LIMITED
ELTS20
In Commercial Distribution

  • 00643293026762 ()


  • Operating table patient pressure distribution pad, reusable
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