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Na 3346

by St. Jude Medical, Inc.

Ref 3346

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

CE MDR

Valid until

11 Oct 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067SCS0001L4 Basic UDI-DI 05414734402309UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734402309 UDI-DI Date25 Apr 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 750959 Expiring Supplemented Expires in 339 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    24 Jun 2026
    Expires
    11 Oct 2027
    Reason
    Add device or group

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension
Device Name
Spinal Cord Stimulation
Model / Ref / Catalog
3346
Primary DI / UDI-DI
05414734402309
Basic UDI-DI
5415067SCS0001L4
510(k) Number
FDA Product Code
GZB
EMDN Code
J020299 Spinal implantable neurostimulators - other
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
882.5880
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension

Cleared under the same submission (K032751)

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

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

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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