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iBur 5407-120-300

by Stryker Corp.

Ref 5407-120-300Model 08858251002014RV

iBur 5407-120-300 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 08858251002014RV) and listed in FDA GUDID since 12 Aug 2021 (UDI-DI 07613327501308), 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 Number08858251002014RV Basic UDI-DI 07613327501308UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327501308 UDI-DI Date12 Aug 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002014RV registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327501308 listed 12 Aug 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327501308
  2. Registered EUDAMED 08858251002014RV

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  • Withdrawn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
iBur
Generic name
Drilling power tool attachment, basic
Device name
iBur Hubs
Model / Ref / Catalog
5407-120-300, 08858251002014RV
Primary DI / UDI-DI
07613327501308
Basic UDI-DI
08858251002014RV
Direct marketing DI
07613327501308
FDA product code
ERL
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Drilling power tool attachment, basic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4250
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
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Drilling power tool attachment, basic

Similar devices

Also classified as Drilling power tool attachment, basic.

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)