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Instrument 1020-1800

by Howmedica Osteonics Corp.

Ref 1020-1800Model 08858250000797SX

Instrument 1020-1800 is a device classified as Class I in the EU and Class II in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 17 Jul 2026 (Basic UDI-DI 08858250000797SX) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327243475), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000797SX Basic UDI-DI 07613327243475UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327243475 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000797SX registered 17 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327243475 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327243475
  2. Registered EUDAMED 08858250000797SX

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  • Withdrawn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
Instrument
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
TF-018 Class I (r) - Inserting/Extracting
Model / Ref / Catalog
1020-1800, 08858250000797SX
Primary DI / UDI-DI
07613327243475
Basic UDI-DI
08858250000797SX
Direct marketing DI
07613327243475
FDA product code
LZO, HWC, JDI, MAY, MBL, KWL, LPH, KWY, MEH, KWZ, LWJ
EMDN code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3040, 888.3350, 888.3358, 888.3360, 888.3390, 888.3310
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: Orthopaedic inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

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