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Integra Essential Shunt Kit NL8504112

by Integra Lifesciences Corp.

Ref NL8504112

Integra Essential Shunt Kit NL8504112 is a device classified as Class III in the EU and Class II in the US made by Integra Lifesciences Corp., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI B-10381780356134), cleared under FDA 510(k) K153041 on 14 Mar 2016 (1 earlier submission) and listed in FDA GUDID since 5 Mar 2019 (UDI-DI 10381780356134), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153041

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780356134 Basic UDI-DI 10381780356134UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780356134 UDI-DI Date5 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153041 Date14 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780356134 registered 6 Oct 2026 Active
  • FDA 510(k) K153041 decided 14 Mar 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10381780356134 listed 5 Mar 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K973525
  2. Cleared FDA 510(k) K153041
  3. Listed FDA GUDID 10381780356134
  4. Registered EUDAMED B-10381780356134

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Integra Essential Shunt Kit
Generic name
Ventriculoperitoneal shunt
Device name
CSF Drainage Systems
Model / Ref / Catalog
NL8504112
Primary DI / UDI-DI
10381780356134
Basic UDI-DI
B-10381780356134
510(k) Number
FDA product code
JXG
EMDN code
C019016 Peritoneovenous shunts
GMDN term
Ventriculoperitoneal shunt
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Ventriculoperitoneal shunt

Cleared under the same submission (K153041)

and 8 more cleared under K153041

Cleared under the same submission (K973525)

Similar devices

Also classified as Ventriculoperitoneal shunt.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)