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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 Negative Control - 10850046056052

Platelet PGDprime Negative Control for quality control testing of the Platelet PGDprime Test System.
Verax Biomedical Incorporated
P01113
In Commercial Distribution

  • 10850046056052 ()


  • 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 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

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

KinesiaU (iOS) - 00859584006102

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

  • 00859584006102 ()
700-0026

  • Tremor transducer

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

Bionic Circle App, iOS - 00850050080169

Bionic Circle App, iOS
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display

Novidan - 00850049194464

Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal

Oticon - 05707131395474

OTICON ON 2.1.0 IOS
Oticon A/S
219645
In Commercial Distribution

  • 05707131395474 ()


  • Hearing aid/implant system remote control
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