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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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Tissue-Tek Genie® - 00615233008947

anti-IgG4 Mouse Monoclonal Antibody [HP6025], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8384-M250
In Commercial Distribution

  • 00615233008947 ()
8384-M250

  • Immunoglobulin G subclass (IgG subclass) IVD, antibody

STRADIS HEALTHCARE - M752ZZ07000

HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution

  • M752ZZ07001 ()
  • M752ZZ07000 ()


  • Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control

COOLIEF* Cooled RF Introducer - 10680651442083

Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44208
In Commercial Distribution

  • 10680651442083 ()
CRI-17-100-4

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

COOLIEF* Cooled RF Introducer - 10680651442076

Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44207
In Commercial Distribution

  • 10680651442076 ()
CRI-17-75-5.5

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

COOLIEF* - 00193493442102

COOLIEF* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
CRI-17-150-6
In Commercial Distribution

  • 10193493442109 ()
  • 00193493442102 ()
CRI-17-150-6

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator

Simpli - 20357515745051

Simpli 8mm Pen Needle UltiGuard
ULTIMED, INC.
74505
In Commercial Distribution

  • 30357515745058 ()
  • 20357515745051 ()
  • 00357515710055 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator

Simpli - 20357515745037

Simpli 6mm Pen Needle UltiGuard
ULTIMED, INC.
74503
In Commercial Distribution

  • 30357515745034 ()
  • 20357515745037 ()
  • 00357515710147 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator

Trident - 04546540516879

Alpha Code H
Howmedica Osteonics Corp.
625-0T-36H
In Commercial Distribution

  • 04546540516879 ()

  • Degree: 0.0 Degree
  • Lumen/Inner Diameter: 36.0 Millimeter
625-0T-36H

  • Ceramic acetabular liner

Trident - 04546540516862

Alpha Code G
Howmedica Osteonics Corp.
625-0T-36G
In Commercial Distribution

  • 04546540516862 ()

  • Lumen/Inner Diameter: 36.0 Millimeter
  • Degree: 0.0 Degree
625-0T-36G

  • Ceramic acetabular liner

Trident - 04546540516855

Alpha Code F
Howmedica Osteonics Corp.
625-0T-32F
In Commercial Distribution

  • 04546540516855 ()

  • Lumen/Inner Diameter: 32.0 Millimeter
  • Degree: 0.0 Degree
625-0T-32F

  • Ceramic acetabular liner
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