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5407-010-970

by Stryker Corp.

Ref 5407-010-970Model 08858251002016RZ

5407-010-970 (5407010970) is a Class I device made by Stryker Corp., registered in EUDAMED on 16 Jul 2026 (Basic UDI-DI 08858251002016RZ) and listed in FDA GUDID since 23 Sep 2018 (UDI-DI 07613327381443), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002016RZ Basic UDI-DI 07613327381443UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327381443 UDI-DI Date23 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002016RZ registered 16 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327381443 listed 23 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327381443
  2. Registered EUDAMED 08858251002016RZ

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  • Withdrawn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
Surgical irrigation tubing set, single-use
Device name
Irrigation Sleeves
Model / Ref / Catalog
5407-010-970, 08858251002016RZ, 5407010970
Primary DI / UDI-DI
07613327381443
Basic UDI-DI
08858251002016RZ
FDA product code
GBX
EMDN code
A0380 Tubular devices - accessories
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class I
Regulation number
878.4200
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical irrigation tubing set, single-use

Similar devices in this category

Other devices filed under TUBULAR DEVICES - ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)