Home GUDID 04048551211007 n.a.
Primary DI 04048551211007
Brand n.a.
Company Karl Storz GmbH & Co. KG
Model 8575RA
Device description Teeth Protector, large
Published 2018-09-04
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 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 04048551211007 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04048551211007 04048551211007 4048551211007
GMDN Terms# Term, Definition table Term Definition Intubation teeth protector A sterile curved device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. Such protection can be required when the patient is resisting the intubation by clenching their teeth which can be damaged against the metal or plastic blade of the intubation laryngoscope, and/or if the patient has bad teeth that are liable to inadvertent damage, and/or if this is normal hospital procedure to counter liability claims. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 315731430 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