Home GUDID 07500463968303 Osto System
Primary DI 07500463968303
Brand Osto System
Company Solomed, S.A. de C.V.
Model Adult
Device description Bag for Colostomy or ileostomy
Published 2019-05-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name FON Bag, Drainage, With Adhesive, Ostomy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07500463968303 Primary GS1 0 17500463968300 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07500463968303 07500463968303 7500463968303 17500463968300 17500463968300
GMDN Terms# Term, Definition table Term Definition One-piece intestinal ostomy bag, open-ended A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.
Regulatory Flags# DUNS number 588625921 Device count 10 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B674WIKB1401101 Perilav Stiehl Tech, LLC FON 2026-05-13 B674WIKB1402101 Perilav Stiehl Tech, LLC FON 2026-05-13 B674WIKB2001101 Perilav Stiehl Tech, LLC FON 2026-05-13 B674WIKE1401101 Perilav Stiehl Tech, LLC FON 2026-05-13 B674WIKE2001101 Perilav Stiehl Tech, LLC FON 2026-05-13 00768455126798 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126804 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126811 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126828 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126835 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126842 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126859 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126866 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126873 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126880 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126897 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126903 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126910 Eakin T.G. EAKIN LIMITED FON 2023-05-16 00768455126927 Eakin T.G. EAKIN LIMITED FON 2023-05-16 16937359412394 Maidwoc Wuhan Sitaili Medical Apparatus Development Co., Ltd. FON 2023-04-19 16937359412387 Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd. FON 2022-12-21 16937359412370 Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd. FON 2022-12-15 16937359412356 Steadlive Wuhan Sitaili Medical Apparatus Development Co., Ltd. FON 2022-12-07 00768455105670 NATURA CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455111916 ESTEEM+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455111985 ESTEEM+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455111992 ESTEEM+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455112036 ESTEEM+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455113330 NATURA+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29 00768455114818 ESTEEM SYNERGY+ CONVATEC, PURCHASING DEPARTMENT FON 2022-09-29