Home GUDID 04038653013869 AESCULAP
Primary DI 04038653013869
Brand AESCULAP
Company Aesculap AG
Model OP299
Catalog number OP299
Device description TEETH PROTECTOR
Published 2020-05-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name LRC INSTRUMENT, ENT MANUAL SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRC Instrument, Ent Manual Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04038653013869 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04038653013869 04038653013869 4038653013869
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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 315018218 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776422653 Millennium Avalign Technologies, Inc. LRC 2026-08-03 00190776422660 Millennium Avalign Technologies, Inc. LRC 2026-08-03 00190776422684 Millennium Avalign Technologies, Inc. LRC 2026-08-03 00190776422462 Millennium Avalign Technologies, Inc. LRC 2026-07-31 00190776422523 Millennium Avalign Technologies, Inc. LRC 2026-07-31 00190776422585 Millennium Avalign Technologies, Inc. LRC 2026-07-31 09348811102645 INKA The Trustee for KAISER FAMILY TRUST LRC 2026-07-31 09348811102669 INKA The Trustee for KAISER FAMILY TRUST LRC 2026-07-31 00198506093593 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-29 00198506093777 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-29 00198506093807 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-29 00198506093814 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-29 B382SD9200321000 Surgical Direct Surgical Direct, Inc. LRC 2026-07-29 B382SD9200321060 Surgical Direct Surgical Direct, Inc. LRC 2026-07-29 B382SD9200321070 Surgical Direct Surgical Direct, Inc. LRC 2026-07-29 00190776422080 Millennium Avalign Technologies, Inc. LRC 2026-07-28 00198506092442 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506092633 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506092664 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506092763 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506092787 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506092824 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093043 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093050 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093067 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093074 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093098 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093159 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506093227 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-28 00198506091896 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-22