Home GUDID 00850071298383 STX4
Primary DI 00850071298383
Brand STX4
Company Hyperion Medical Technologies, Inc.
Model HMSTX0004
Device description Neuropathy Assessment Device
Published 2026-06-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LQW Test, Temperature Discrimination
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LQW Test, Temperature Discrimination Neurology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850071298383 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850071298383 00850071298383 850071298383 0850071298383
GMDN Terms# Term, Definition table Term Definition Vibratory biothesiometer An electronic instrument intended to produce vibrations that are applied to a part of the body (often the great toe) in a range of intensities to noninvasively measure vibratory sensation threshold. Sometimes referred to as a vibrameter, It is typically used for neuropathological diagnoses and evaluation of the neurological health effects of diabetes mellitus, exposure to neurotoxic compounds (e.g., solvents or heavy metals), poor ergonomic working conditions, chemotherapy or trauma.
Regulatory Flags# DUNS number 008992962 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850071298017 Smart-RST SAWT-XXXX 2026-06-02 00850071298390 Monofilament Set STX4MF0125US 2026-06-02
Other Devices Sharing Product Codes#