Home GUDID 08904461055697 OSSEOUS-Capsule
Primary DI 08904461055697
Brand OSSEOUS-Capsule
Company EON MEDITECH PRIVATE LIMITED
Model EA910018
Published 2026-03-13
Public version status New
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 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 08904428798377 Package GS1 15 In Commercial Distribution 08904461055697 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08904428798377 08904428798377 8904428798377 08904461055697 08904461055697 8904461055697
GMDN Terms# Term, Definition table Term Definition Tracheoesophageal device insertion capsule A non-sterile, smooth, capsule-like device intended to house/cover a tracheoesophageal device (e.g., speech valve, fistula gauge) at the distal end of the introduction assembly, to enable atraumatic insertion of the device into the tracheoesophageal fistula (puncture). It is a synthetic polymer gelatinous casing intended to dissolve in situ for subsequent digestion; disposable devices intended to assist mounting may be included. It is intended to be used in the home and healthcare facility, and may be used in conjunction with a lubricant. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 25 Degrees Celsius 0 Degrees Celsius
Regulatory Flags# DUNS number 930270428 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 00190776432263 Millennium Avalign Technologies, Inc. LRC 2026-09-24 00190776432270 Millennium Avalign Technologies, Inc. LRC 2026-09-24 00190776431440 Millennium Avalign Technologies, Inc. LRC 2026-09-22 00190776432140 Millennium Avalign Technologies, Inc. LRC 2026-09-22 00190776428020 Millennium Avalign Technologies, Inc. LRC 2026-08-27 00190776428174 Millennium Avalign Technologies, Inc. LRC 2026-08-27 00844505014762 BONE WAX APPLICATOR Grace Medical, Inc. LRC 2026-08-27 00190776427566 Millennium Avalign Technologies, Inc. LRC 2026-08-26 04054462913633 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913732 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913763 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913794 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913824 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913831 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913855 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462913893 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914005 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914012 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914036 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914067 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914074 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914081 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914098 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914104 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914111 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914142 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914203 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914234 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914241 evonos evonos GmbH & Co. KG LRC 2026-08-25 04054462914258 evonos evonos GmbH & Co. KG LRC 2026-08-25