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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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JEDMED - M6333974200

HANDLE & CHARGER F/HORUS SCOPE
JEDMED INSTRUMENT COMPANY
39-7420
In Commercial Distribution

  • M6333974200 ()
39-7420

  • Ophthalmic fundus camera

JEDMED - M6333974080

BATTERY F/HORUS +DIGITAL OTOSCOPE
JEDMED INSTRUMENT COMPANY
39-7408
In Commercial Distribution

  • M6333974080 ()
39-7408

  • Ophthalmic fundus camera

JEDMED - M6333974050

HORUS + DIGITAL OTOSCOPE
JEDMED INSTRUMENT COMPANY
39-7405
In Commercial Distribution

  • M6333974050 ()
39-7405

  • Ophthalmic fundus camera

HiPAL Pro - G527GTDHIPALPRO01V1010

HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self- administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution

  • G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01

  • Cognitive assessment software

Tenovi - G004TCCBP010

Tenovi Cellular Blood Pressure Monitor
Tenovi Co.
TC-CBP-01
In Commercial Distribution

  • G004TCCBP010 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMS20

Tenovi Bluetooth Blood Pressure Monitor - Small Cuff Size
Tenovi Co.
TC-BPM-S2
In Commercial Distribution

  • G004TCBPMS20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPML20

Tenovi Bluetooth Blood Pressure Monitor - Large Cuff Size
Tenovi Co.
TC-BPM-L2
In Commercial Distribution

  • G004TCBPML20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMA20

Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A2
In Commercial Distribution

  • G004TCBPMA20 ()


  • Telemetric sphygmomanometer

Tenovi - G004TCBPMA10

Bluetooth Blood Pressure Monitor
Tenovi Co.
TC-BPM-A1
In Commercial Distribution

  • G004TCBPMA10 ()


  • Telemetric sphygmomanometer

Bowman Perfusion Monitor, 240V - B238H000107110

Perfusion Monitor, 240V
HEMEDEX, INC
Model 500
In Commercial Distribution

  • B238H000107110 ()
H0001-0711

  • Patient monitoring system module, intracranial pressure
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