Home GUDID 00866330000208 SmartGuard
Primary DI 00866330000208
Brand SmartGuard
Company Smartguard Rx, Inc.
Model SGDG6
Device description Dental mouth guard for clenching and grinding teeth (bruxism)
Published 2020-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true Product Codes# Code, Name table Code Name MQC Mouthguard, Prescription OBR Mouthguard, Over-The-Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQC Mouthguard, Prescription Unknown U OBR Mouthguard, Over-The-Counter Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10866330000205 Package GS1 3 In Commercial Distribution 20866330000202 Package GS1 4 In Commercial Distribution 30866330000209 Package GS1 12 In Commercial Distribution 00866330000208 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 10866330000205 10866330000205 20866330000202 20866330000202 30866330000209 30866330000209 00866330000208 00866330000208 866330000208 0866330000208
GMDN Terms# Term, Definition table Term Definition Mouthguard, reusable A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.
Regulatory Flags# DUNS number 079556398 Device count 1 Lot or batch true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00866330000260 SmartGuard SGASD 2021-11-05 10866330000205 SmartGuard SGDG6 2020-09-24
Other Devices Sharing Product Codes# 
smartguardrx.com