Home GUDID 00618029810328 Toothette Oral Care
Primary DI 00618029810328
Brand Toothette Oral Care
Company SAGE PRODUCTS, LLC
Model 4000
Catalog number 4000
Device description Disposable Bite Block for Oral Control
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name BRW PROTECTOR, DENTAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BRW Protector, Dental Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50618029810323 Package GS1 144 In Commercial Distribution 00618029810328 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 50618029810323 50618029810323 00618029810328 00618029810328 618029810328 0618029810328
GMDN Terms# Term, Definition table Term Definition Mouthguard, single-use A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.
Regulatory Flags# DUNS number 054326178 Device count 1 DM exempt false Premarket exempt true 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 true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04250676748188 Endoragard teeth protector Spiggle & Theis Medizintechnik GmbH BRW 2026-04-27 08800017902289 EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTD BRW 2025-12-18 08800017902296 EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTD BRW 2025-12-18 08800017902302 EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTD BRW 2025-12-18 08800017902319 EZ BITE BLOCK SOFT MOUTH PROP DXM CO., LTD BRW 2025-12-18 08800017901817 EZ Bite block DXM CO., LTD BRW 2025-12-16 08800017900605 EZ Bite block DXM CO., LTD BRW 2025-12-16 00194613123468 MSI Precision Specialty Instruments Med Saver, Inc. BRW 2025-08-01 08800142100949 Tera Harz Guard Graphy Inc. BRW 2025-07-18 00885797099365 RMO Rmo, Inc. BRW 2024-09-02 00885797099372 RMO Rmo, Inc. BRW 2024-09-02 00885797099396 RMO Rmo, Inc. BRW 2024-09-02 00885797099402 RMO Rmo, Inc. BRW 2024-09-02 00885797672278 RMO Rmo, Inc. BRW 2024-08-26 00885797672292 RMO Rmo, Inc. BRW 2024-08-26 00000008857972 RMO Rmo, Inc. BRW 2024-08-12 10889483007563 SunMed SUNMED, LLC BRW 2024-03-12 08800075604170 OSUNG MND OSUNG MND Co., Ltd. BRW 2024-02-19 08800075604187 OSUNG MND OSUNG MND Co., Ltd. BRW 2024-02-19 08800075604194 OSUNG MND OSUNG MND Co., Ltd. BRW 2024-02-19 00630094199702 Bioseal Inc. BIOSEAL BRW 2023-12-12 10630094199709 Bioseal Inc. BIOSEAL BRW 2023-12-12 00630094199207 Bioseal Inc. BIOSEAL BRW 2023-12-11 00630094199252 Bioseal Inc. BIOSEAL BRW 2023-12-11 00630094199306 Bioseal Inc. BIOSEAL BRW 2023-12-11 00630094199320 Bioseal Inc. BIOSEAL BRW 2023-12-11 10630094199204 Bioseal Inc. BIOSEAL BRW 2023-12-11 10630094199259 Bioseal Inc. BIOSEAL BRW 2023-12-11 10630094199303 Bioseal Inc. BIOSEAL BRW 2023-12-11 10630094199327 Bioseal Inc. BIOSEAL BRW 2023-12-11
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