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Disposable ERCP Cannula 5004

by TeleMed Systems

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00813353010752 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Disposable ERCP Cannula
Generic Name
ERCP catheter, non-balloon, non-electrical, single-use
Model / Reference
5004
Description
ERCP Cannula 3mm Tip Taper 5.0fr x 200cm
Primary DI / UDI-DI
00813353010752
510(k) Number
FDA Product Code
FGE
GMDN Term
ERCP catheter, non-balloon, non-electrical, single-use
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K901431)

Other devices from TeleMed Systems

See all devices from TeleMed Systems →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

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