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UltraMax 52500

by Marlen Manufacturing And Development Co.

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 Number10661613525006 UDI-DI Date28 Apr 2026ListedStatusListed 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  • Withdrawn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
UltraMax
Generic Name
One-piece intestinal ostomy bag, open-ended, single-use
Model / Reference
52500
Primary DI / UDI-DI
10661613525006
FDA Product Code
EZS
GMDN Term
One-piece intestinal ostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
GUDID distribution status
In Commercial Distribution

Other devices from Marlen Manufacturing And Development Co.

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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