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0606100000

by Stryker Corp.

Ref 0606-100-000Model 08858250000484S7

0606100000 (0606-100-000) is a Class I device made by Stryker Corp., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08858250000484S7) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 07613154259793), active as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000484S7 Basic UDI-DI 07613154259793UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154259793 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000484S7 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 07613154259793 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154259793
  2. Registered EUDAMED 08858250000484S7

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  • Withdrawn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 implantable material dispenser, cartridge-/syringe-accepting, reusable
Device name
Cement Gun
Model / Ref / Catalog
08858250000484S7, 0606-100-000, 0606100000
Primary DI / UDI-DI
07613154259793
Basic UDI-DI
08858250000484S7
Direct marketing DI
07613154259793
FDA product code
KIH
EMDN code
P099002 Orthopaedic cement preparation and application devices and kits
GMDN term
Orthopaedic implantable material dispenser, cartridge-/syringe-accepting, reusable
Device class
Class I
Regulation number
888.4200
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858250000484S7
0606-100-000
GUDID
0606100000

Related devices

Category: Orthopaedic cement/bone filler dispensing gun

Similar devices in this category

Other devices filed under ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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