Home GUDID 10866330000205 SmartGuard
Primary DI 10866330000205
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 New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC true
Sterile false
Single use false Product Codes# Code, Name table Code Name OBR Mouthguard, Over-The-Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class 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 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 intended for single-patient use.
Regulatory Flags# DUNS number 079556398 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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 00866330000260 SmartGuard SGASD 2021-11-05 00866330000208 SmartGuard SGDG6 2020-09-24
Other Devices Sharing Product Codes# 
smartguardrx.com