Skip to content

SharkCore DSL-19-01

by Covidien LP

Ref DSL-19-01

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10884521833081 UDI-DI Date6 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0763000B00014798G Basic UDI-DI 10884521833081UDI-DIDate22 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SharkCore™ EUDAMED
SharkCore GUDID
Generic Name
General-purpose endoscopic needle, single-use
Model / Reference
DSL-19-01
Primary DI / UDI-DI
10884521833081
Basic UDI-DI
0763000B00014798G
510(k) Number
FDA Product Code
FCG
EMDN Code
A0199 Needles - other
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1075
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 19 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No