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5450800317

by Stryker Corp.

Part of a family of 12 devices: see the family page

Ref 5450-800-317Model 08858251002038SB

5450800317 is a device classified as Class IIa (EU), Unclassified (US) made by Stryker Corp., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 08858251002038SB) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613252518372), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002038SB Basic UDI-DI 07613252518372UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252518372 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002038SB registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 07613252518372 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252518372
  2. Registered EUDAMED 08858251002038SB

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  • Withdrawn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
Soft-tissue ultrasonic surgical system handpiece tip, single-use
Device name
Sonopet 1 Univ Tips
Model / Ref / Catalog
08858251002038SB EUDAMED
5450-800-317 EUDAMED
5450800317 GUDID
Primary DI / UDI-DI
07613252518372
Basic UDI-DI
08858251002038SB
FDA product code
LFL
EMDN code
K02020199 Ultrasonic surgery instruments, single-use - other
GMDN term
Soft-tissue ultrasonic surgical system handpiece tip, single-use
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002038SB
5450-800-317
GUDID
5450800317
Device classEUDAMED
Class IIa
GUDID
U

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

Related devices

Category: Soft-tissue ultrasonic surgical system handpiece tip, single-use

Similar devices in this category

Other devices filed under ULTRASONIC SURGERY INSTRUMENTS, SINGLE-USE.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)