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EVOLVE Proline 24981002

by Wright Medical Technology, Inc.

Ref 24981002Model 08858251028206U8

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 7 Nov 2026.

Overview

The EVOLVE Proline is a versatile hand-held manual surgical instrument designed to attach to the proximal end of various instruments for controlled manipulations, providing precision and reliability in surgical procedures. This device is made from metal and/or synthetic materials, featuring a straight or T-shaped handle grip with additional features such as a ratchet mechanism.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251028206U8 Basic UDI-DI 00840420191311UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840420191311 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028206U8 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00840420191311 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840420191311
  2. Registered EUDAMED 08858251028206U8

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  • Withdrawn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
Evolve™ EUDAMED
EVOLVE Proline GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Evolve Proline Instrumentation - Handles and Adaptors - Class I - Nonsterile
Model / Ref / Catalog
24981002, 08858251028206U8
Primary DI / UDI-DI
00840420191311
Basic UDI-DI
08858251028206U8
Direct marketing DI
00840420191311
FDA product code
LXH
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Wright Medical Technology, Inc.

See all devices from Wright Medical Technology, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)