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Enztec Classic OCI - Trinket 7 /16-20 UNF-02 4252-2099

by Enztec Limited

Ref 4252-2099

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number942102811GMN00092B Basic UDI-DI 09421028115643UDI-DIDate1 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number09421028115643 UDI-DI Date6 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Enztec Classic OCI - Trinket 7/16-20 UNF-02 EUDAMED
Enztec Classic OCI - Trinket 7 /16-20 UNF-02 GUDID
Generic Name
Orthopaedic implant impactor, reusable
Device Name
Enztec Cup Impactors
Model / Ref / Catalog
4252-2099
Primary DI / UDI-DI
09421028115643
Basic UDI-DI
942102811GMN00092B
FDA Product Code
HWA
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No