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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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CUPTIMIZE - 10603295551270

Cuptimize for Ios
DEPUY ORTHOPAEDICS, INC.
451580054
In Commercial Distribution

  • 10603295551270 ()
451580054

  • Orthopaedic stereotactic surgery system

CUPTIMIZE Advanced - 10603295552109

CUPTIMIZE Advanced iOS
DEPUY (IRELAND)
4515-80-071
In Commercial Distribution

  • 10603295552109 ()
451580071

  • Orthopaedic stereotactic surgery system

Platelet PGDprime Controls - 10850046056151

Platelet PGDprime Positive and Negative Controls for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
PRM30C
In Commercial Distribution

  • 10850046056151 ()
PRM30C

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Reagents, 20 Test - 10850046056144

Platelet PGDprime Reagents required to perform the Platelet PGDprime Test System. 20 test kit
Verax Biomedical Incorporated
PRM20R
In Commercial Distribution

  • 10850046056144 ()
PRM20R

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Reagents, 100 Test - 10850046056137

Platelet PGDprime Test Reagents required for processing the sample prior to testing with the Platelet PGDprime Test Device. 100 test kit
Verax Biomedical Incorporated
PRM100R
In Commercial Distribution

  • 10850046056137 ()
PRM100R

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer Pipettes - 10850046056120

Platelet PGDprime Test System required disposable sample pipettes, processing tubes and transfer pipettes. 100 test kit
Verax Biomedical Incorporated
PRM100D
In Commercial Distribution

  • 10850046056120 ()
PRM100D

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Test, 20 devices plus disposables - 10850046056113

Kit includes 20 Platelet PGDprime Test devices plus sample pipettes, transfer pipettes and sample processing tubes required to run the Platelet PGDprime Test System.
Verax Biomedical Incorporated
PRM20T
In Commercial Distribution

  • 10850046056113 ()
PRM20T

  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Processing Tubes - 10850046056090

Platelet PGDprime Processing Tubes are required for processing the platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01463
In Commercial Distribution

  • 10850046056236 ()
  • 10850046056090 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Transfer Pipettes - 10850046056083

Platelet PGDprime Transfer Pipettes required to move the processed platelet sample to the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01229
In Commercial Distribution

  • 10850046056243 ()
  • 10850046056083 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical

Platelet PGDprime Processing Tubes - 10850046056076

Platelet PGDprime Processing Tubes are used to contain the platelet sample while processing with Reagents 1A, 1B and 2.
Verax Biomedical Incorporated
P01462
In Commercial Distribution

  • 10850046056236 ()
  • 10850046056076 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
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