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Generic Instruments OLIVE-1.6/100

by Trimed, INC.

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

Ref OLIVE-1.6/100Model Wire

Generic Instruments OLIVE-1.6/100 is a device classified as Class IIa in the EU and Class II in the US made by Trimed, INC., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 08421881WIREPZ), cleared under FDA 510(k) K010545 on 6 Jun 2001 and listed in FDA GUDID since 26 Jul 2019 (UDI-DI 00842188119859), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K010545

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08421881WIREPZ Basic UDI-DI 00842188119859UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842188119859 UDI-DI Date26 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010545 Date6 Jun 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08421881WIREPZ registered 3 Nov 2026 Active
  • FDA 510(k) K010545 decided 6 Jun 2001 Active
  • FDA GUDID UDI-DI 00842188119859 listed 26 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010545
  2. Listed FDA GUDID 00842188119859
  3. Registered EUDAMED 08421881WIREPZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Single-Use, Disposable Instruments EUDAMED
Generic Instruments GUDID
Generic name
Orthopaedic intraoperative positioning pin, single-use
Model / Ref / Catalog
OLIVE-1.6/100, Wire
Primary DI / UDI-DI
00842188119859
Basic UDI-DI
08421881WIREPZ
510(k) Number
FDA product code
NDL
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic intraoperative positioning pin, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Ireland
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Orthopaedic intraoperative positioning pin, single-use

Cleared under the same submission (K010545)

and 4 more cleared under K010545

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Trimed, INC.

See all devices from Trimed, INC. →

Properties

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