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Assura 12170

by Coloplast A/S

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00762123033661 UDI-DI Date11 Mar 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Assura
Generic Name
One-piece intestinal ostomy bag, closed-ended
Model / Ref / Catalog
12170
Description
Alterna Flex ostomy bag / Assura Flex ostomy bag. Base Plate Precut Start Hole Size 20 mm, Base Plate Max Cut Size 75 mm, Base Plate Type Flat.
Primary DI / UDI-DI
00762123033661
FDA Product Code
EXB
GMDN Term
One-piece intestinal ostomy bag, closed-ended
Device Class
Class I
Regulation Number
876.5900
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: One-piece intestinal ostomy bag, closed-ended

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No