Home GUDID 00860313000827 NTI-tss Plus
Primary DI 00860313000827
Brand NTI-tss Plus
Company KELLER LABORATORIES, INC.
Model 1
Device description The NTI-tss Plus is designed to reduce the intensity of clenching while treating migraine pain and frequency.
Published 2026-04-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OCO Mouthguard, Migraine/Tension Headache
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OCO Mouthguard, Migraine/Tension Headache Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860313000827 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 00860313000827 00860313000827 860313000827 0860313000827
GMDN Terms# Term, Definition table Term Definition Custom-made mouthguard A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.
Regulatory Flags# DUNS number 801156050 Device count 1 Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860313000803 ClearDream ClearDream 2018-03-27
Other Devices Sharing Product Codes#