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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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BioPlex 2200 - 03610520563939

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520506462

BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520506349

25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution

  • 03610520506349 ()

  • 1 Each
6653775A

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520150269

BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Soprano® 10 Livento® press - 07640173094791

Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software

Task Force® Monitor Software - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

Persona® - 00889024245730

No Description
Zimmer, Inc.
42-5279-002-04
In Commercial Distribution

  • 00889024245730 ()

  • Size CD 14 mm Thickness
42-5279-002-04

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245723

No Description
Zimmer, Inc.
42-5279-002-03
In Commercial Distribution

  • 00889024245723 ()

  • Size CD, 13 mm Thickness
42-5279-002-03

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024245716

No Description
Zimmer, Inc.
42-5279-002-02
In Commercial Distribution

  • 00889024245716 ()

  • Size CD 12 mm Thickness
42-5279-002-02

  • Knee tibia prosthesis trial, reusable
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