Home GUDID 00385640014601 NA
Primary DI 00385640014601
Brand NA
Company Summit Medical, Inc.
Model OT-1700
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name ETD Tube, Tympanostomy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETD Tube, Tympanostomy Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10385640014608 Package GS1 1 In Commercial Distribution 00385640014601 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 10385640014608 10385640014608 00385640014601 00385640014601 385640014601 0385640014601
GMDN Terms# Term, Definition table Term Definition Tympanostomy tube A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes.
Regulatory Flags# DUNS number 965484699 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M6333816500 JEDMED JEDMED INSTRUMENT COMPANY ETD 2023-05-08 00385640073509 NA Summit Medical, Inc. ETD 2023-01-11 00385640068604 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068611 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068628 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068635 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068659 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068666 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068673 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068680 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068697 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068703 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068710 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068727 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068734 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068741 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068758 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068765 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068796 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068802 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068819 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068826 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068833 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068840 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068857 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068864 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068871 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068888 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068895 Summit Medical Summit Medical, Inc. ETD 2022-10-06 00385640068901 Summit Medical Summit Medical, Inc. ETD 2022-10-06