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 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 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 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 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
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 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 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 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
Platelet PGDprime Sample Pipettes for adding the platelet sample to the processing tube.
Verax Biomedical Incorporated
P01230
In Commercial Distribution

  • 10850046056250 ()
  • 10850046056069 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
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 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 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 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 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 single device pouch
Verax Biomedical Incorporated
T.00001186E
In Commercial Distribution

  • 10850046056007 ()
  • 10850046056106 ()


  • Lipoteichoic acid (LTA)/lipopolysaccharide (LPS) IVD, kit, rapid ICT, clinical
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
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 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 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
Beta Bionics, Inc.
BOM000082
In Commercial Distribution

  • 00850050080169 ()
BB5001

  • Ambulatory insulin infusion pump software, data-display
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
t:connect Mobile Application (iOS)
Tandem Diabetes Care, Inc.
1004128
In Commercial Distribution

  • 00850006613274 ()


  • Ambulatory insulin infusion pump software, data-display
Cara i500 ios System
Kulzer GmbH
66081716
In Commercial Distribution

  • J014660817160 ()
66081716

  • Dental milling system, CAD/CAM, laboratory
Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
SOUNDLINK 2 1.4 IOS
Sonic Innovations, Inc.
178497
In Commercial Distribution

  • 05711584074695 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.0 IOS
Sonic Innovations, Inc.
204547
In Commercial Distribution

  • 05711583037455 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.8 IOS
Sonic Innovations, Inc.
185787
In Commercial Distribution

  • 05711583030142 ()


  • Hearing aid/implant system remote control
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