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Pangea 542022

by Stryker GmbH

Part of a family of 19 devices: see the family page

Ref 542022Model 08858251003739TP

Pangea 542022 is a device classified as Class IIa in the EU and Class I in the US made by Stryker GmbH, registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI 08858251003739TP) and listed in FDA GUDID since 1 Mar 2024 (UDI-DI 07613327614282), active as of 12 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003739TP Basic UDI-DI 07613327614282UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327614282 UDI-DI Date1 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003739TP registered 27 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327614282 listed 1 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327614282
  2. Registered EUDAMED 08858251003739TP

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  • Withdrawn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
Fluted surgical drill bit, reusable
Device name
Pangea Instruments - Drilling Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
542022, 08858251003739TP
Primary DI / UDI-DI
07613327614282
Basic UDI-DI
08858251003739TP
Direct marketing DI
07613327614282
FDA product code
HWE
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 135.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)