NEURO TOUCH

Basic Information

• Brand Name: NEURO TOUCH
• Primary DI: 08908022363016
• Version / Model: SDNTST0123US
• Company Name: YOSTRA LABS PRIVATE LIMITED
• Labeler DUNS: 874049860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-10
• Public Version: 1
• Public Version Date: 2024-01-18
• Public Version Status: New
• Public Device Record Key: 5350e077-3332-4e74-9861-bb73e6bb6d14

Device Description

NEURO TOUCH is a point of care screening device for Peripheral Neuropathy. Perform the following tests using NEURO TOUCH: Protective Sensation Test (Monofilament Test) Vibration Perception Test Hot and Cold Perception Test.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXB	Esthesiometer	Neurology	882.1500	1
LLN	Device, Vibration Threshold Measurement	Neurology	882.1200	1
LQW	Test, Temperature Discrimination	Neurology	882.1200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37349	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.	No	Active
62780	Pressure algometer/aesthesiometer, electronic	An electrically-powered digital instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force (pressure) to the skin; and 2) tactile sensibility (two-point touch discrimination) by application of a thin filament(s) to the skin. It is a hand-held device with a thin filament(s) with a pre-set flexibility intended to apply a known pressure (e.g., two-point aesthesiometer). It is typically used during diagnosis or treatment of nerve injuries and neuropathies.	No	Active
37350	Thermotester, diagnostic	A mains electricity (AC-powered) device designed to provide quantitative diagnostic evaluation of a patient's reaction to thermal stimuli, typically on the skin surface, by providing information on threshold to heat or cold perception. The device typically operates by gradually increasing the temperature to 42 - 50? Celsius. It is typically used to diagnose early diabetes mellitus, for phantom pain detection, neurological studies of thin fibre nerve systems, and also for pain threshold investigations.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08908022363016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]