Skip to content

Pangea 706449

by Stryker Corp.

Ref 706449Model 08858251003740T8

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003740T8 Basic UDI-DI 07613327539660UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327539660 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 23 Oct 2026.

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  • Withdrawn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

Trade Name
Pangea
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Pangea Instruments - Handles and Adaptors - Class I - Reusable - Non Sterile
Model / Ref / Catalog
706449, 08858251003740T8
Primary DI / UDI-DI
07613327539660
Basic UDI-DI
08858251003740T8
Direct Marketing DI
07613327539660
FDA Product Code
HWC, HRS
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3040, 888.3030
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K222381)

Show all (12)

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No