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SharkCore C-25-05

by Covidien LP 2 variants

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 Number00855208005117 UDI-DI Date8 Sep 2017ListedStatusListed 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  • Withdrawn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
SharkCore
Generic Name
General-purpose endoscopic needle, single-use
Model / Reference
C-25-05
Primary DI / UDI-DI
00855208005117
510(k) Number
FDA Product Code
FCG
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class II
Regulation Number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 25 Gauge

Related devices

Cleared under the same submission (K141894)

Show all (11)

Other devices from Covidien LP

See all devices from Covidien LP →

Properties

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

Other properties (9)

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