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234-030-027

by Stryker Corp.

Ref 234-030-027Model 08858251003400SD

234-030-027 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 08858251003400SD) and listed in FDA GUDID since 9 Sep 2015 (UDI-DI 34546540756504), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003400SD Basic UDI-DI 34546540756504UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number34546540756504 UDI-DI Date9 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003400SD registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 34546540756504 listed 9 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 34546540756504
  2. Registered EUDAMED 08858251003400SD

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  • Withdrawn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

Generic name
Orthopaedic intraoperative positioning pin, reusable
Device name
SMBU_TF10457_Pins and Guidewires
Model / Ref / Catalog
234-030-027, 08858251003400SD
Primary DI / UDI-DI
34546540756504
Basic UDI-DI
08858251003400SD
Unit of use DI
04546540756503
FDA product code
NBH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic intraoperative positioning pin, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.1100
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 14.0 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implantation sleeve, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)