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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DreamMapper Application iOS
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959041943 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper Application iOS
Respironics, Inc.
2.6
In Commercial Distribution

  • 00606959044340 ()
1101478

  • Self-care monitoring/reporting software
G7 iOS App
Dexcom, Inc.
SW12300
In Commercial Distribution

  • 00386270001863 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Modified TG Chisel
HU-FRIEDY MFG. CO., LLC
CTG-O
In Commercial Distribution

  • 10889950007386 ()
CTG-O

  • Periodontal file/rasp, manual
TG Chisel, Modified
HU-FRIEDY MFG. CO., LLC
CTG-O6
In Commercial Distribution

  • 10889950007393 ()
CTG-O6

  • Periodontal file/rasp, manual
TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG6
In Commercial Distribution

  • 10889950007379 ()
CTG6

  • Periodontal file/rasp, manual
TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG
In Commercial Distribution

  • 10889950007362 ()
CTG

  • Periodontal file/rasp, manual
KRAMER NEVINES TG
Power Dental U.S.A. Inc.
2006
In Commercial Distribution

  • D94320060 ()
2006

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
PA-Chisel - TRINOVO - TG
Kohler Medizintechnik GmbH
7645
In Commercial Distribution

  • 04251436926839 ()
7645

  • Orthopaedic chisel
Kirkland #13K/TG
Zoll-Dental
PC-Kirk13K/TG
In Commercial Distribution

  • 00840105209744 ()


  • Periodontal hoe
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
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