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Global Unite 2100-70-150

by Depuy (Ireland)

Ref 2100-70-150Model Surgical Screwdriver

Global Unite 2100-70-150 (210070150) is a Class I device made by Depuy (Ireland), registered in EUDAMED on 23 Dec 2025 (Basic UDI-DI 0603295a000948R) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10603295085942), 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 Number0603295a000948R Basic UDI-DI 10603295085942UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295085942 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a000948R registered 23 Dec 2025 Active
  • FDA GUDID UDI-DI 10603295085942 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295085942
  2. Registered EUDAMED 0603295a000948R

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  • Withdrawn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
Global Unite
Generic name
Surgical screwdriver, reusable
Device name
Surgical Screwdriver
Model / Ref / Catalog
2100-70-150, Surgical Screwdriver, 210070150
Primary DI / UDI-DI
10603295085942
Basic UDI-DI
0603295a000948R
Direct marketing DI
10603295085942
FDA product code
HXX
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

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