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Biliary Drainage Kit 31803

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 Number00661613318038 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  • Withdrawn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
Biliary Drainage Kit
Generic Name
Biliary drain
Model / Reference
31803
Primary DI / UDI-DI
00661613318038
FDA Product Code
EXF
GMDN Term
Biliary drain
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
In Commercial Distribution

Other devices from Marlen Manufacturing And Development Co.

Properties

  • Single Use
  • Implantable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: 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