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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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UNIVERSAL NEURO 2 - 04546540491084

LOW PROFILE PLATE,WITH BAR, 16MM
Stryker Leibinger GmbH & Co. KG
13-05216
In Commercial Distribution

  • 04546540491084 ()

  • Number of Screw Holes: 2.0 Holes
  • Bar Length: 16.0 Millimeter
13-05216

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

UNIVERSAL NEURO 2 - 04546540491077

LOW PROFILE PLATE,WITH BAR 12MM,WITH TAB
Stryker Leibinger GmbH & Co. KG
13-05212
In Commercial Distribution

  • 04546540491077 ()

  • Number of Screw Holes: 2.0 Holes
  • Bar Length: 12.0 Millimeter
13-05212

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

UNIVERSAL NEURO 2 - 04546540491060

LOW PROFILE PLATE,STRAIGHT
Stryker Leibinger GmbH & Co. KG
13-05164
In Commercial Distribution

  • 04546540491060 ()

  • Number of Screw Holes: 16.0 Holes
13-05164

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

VITEK®2 - 03573026619060

VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution

  • 03573026619060 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

VITEK®2 - 03573026553968

VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

VITEK®2 - 03573026145842

VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings
BIOMERIEUX , INC.
27222R
In Commercial Distribution

  • 03573026145842 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

IDS SARS-COV-2 IgG Control Set - 05060169695979

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6530
In Commercial Distribution

  • 05060169695979 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control

IDS-iSYS Ostase® BAP Control Set - 05060169695818

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-2830US
In Commercial Distribution

  • 05060169695818 ()


  • Bone alkaline phosphatase (BALP) IVD, control

IDS SHBG Control Set - 05060169691339

No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-5630
In Commercial Distribution

  • 05060169691339 ()


  • Sex hormone binding globulin (SHBG) IVD, control

CK NAC - 05055273201505

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
RANDOX LABORATORIES LIMITED
CK3878
In Commercial Distribution

  • 05055273201505 ()
CK3878

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent
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