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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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Platelet PGDprime Positive Control - 10850046056045

Platelet PGDprime Positive Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01412
In Commercial Distribution

  • 10850046056045 ()


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

Platelet PGDprime Reagent 2 - 10850046056038

Platelet PGDprime Reagent 2 required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01214
In Commercial Distribution

  • 10850046056038 ()


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

Platelet PGDprime Reagent 1B - 10850046056021

Platelet PGDprime Reagent 1B required for processing platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01413
In Commercial Distribution

  • 10850046056021 ()


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

Platelet PGDprime Reagent 1A - 10850046056014

Platelet PGDprime Reagent 1A required to process the platelet sample prior to testing with the Platelet PGDprime Test Device.
Verax Biomedical Incorporated
P01111
In Commercial Distribution

  • 10850046056014 ()


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

Platelet PGDprime Test - 10850046056007

Platelet PGDprime Test single device pouch
Verax Biomedical Incorporated
T.00001186E
In Commercial Distribution

  • 10850046056007 ()
  • 10850046056106 ()


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

KinesiaU (iOS) - 00859584006102

No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer

OVO IOS - 00864206000437

OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside

Heron IOS - 00864206000406

Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside

VeriPulse IOS - D040706751

VeriPulse IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Veripulse IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
WHIP-MIX CORPORATION
70675
Not in Commercial Distribution

  • D040706751 ()


  • Dental milling system, CAD/CAM, chairside

iCare PATIENT2 - 06430033851098

iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
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