Osto System

GUDID 07500463968327

Bag for Colostomy or ileostomy

Solomed, S.A. de C.V.

One-piece intestinal ostomy bag, open-ended

• Primary Device ID: 07500463968327
• NIH Device Record Key: 3e8aec14-0107-48c3-9160-a42f0ce0e965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osto System
• Version Model Number: Neonatal
• Company DUNS: 588625921
• Company Name: Solomed, S.A. de C.V.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07500463968327 [Primary]
GS1	17500463968324 [Unit of Use]

FDA Product Code

• FON: Bag, Drainage, With Adhesive, Ostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-05-30

On-Brand Devices [Osto System]

• 07500463968334: Equipment for colostomy or ileostomy
• 07500463968327: Bag for Colostomy or ileostomy
• 07500463968310: Bag for Colostomy or ileostomy
• 07500463968303: Bag for Colostomy or ileostomy