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Loop Ostomy Rod 620

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00661613006201 UDI-DI Date3 May 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  • Withdrawn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
Loop Ostomy Rod
Generic Name
Colostomy rod
Model / Reference
620
Primary DI / UDI-DI
00661613006201
FDA Product Code
EZP
GMDN Term
Colostomy rod
Device Class
Class II
Regulation Number
876.4270
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Marlen Manufacturing And Development Co.

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing 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
  • Expiration Date: No