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Na 602-1010

by Stryker Corp. EUDAMEDGUDID

Active European Union

Ref 602-1010Model 08858251002815T7

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002815T7 Basic UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886385006604 UDI-DIDate24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
AutoFIX
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Autofix Instruments - Trays and Tray Accessories - Class I - Non Sterile
Model / Ref / Catalog
602-1010, 08858251002815T7
Primary DI / UDI-DI
00886385006604
Basic UDI-DI
08858251002815T7
Direct Marketing DI
00886385006604
FDA Product Code
LRP
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No