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Instrument 2107-2200

by Howmedica Osteonics Corp.

Ref 2107-2200Model 08858251003214SE

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 Number08858251003214SE Basic UDI-DI 07613327212327UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327212327 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
Hip Instr EUDAMED
Instrument GUDID
Generic Name
Fluted surgical drill bit, reusable
Device Name
TF-019 Class IIa - Drill Bit
Model / Ref / Catalog
2107-2200, 08858251003214SE
Primary DI / UDI-DI
07613327212327
Basic UDI-DI
08858251003214SE
Direct Marketing DI
07613327212327
FDA Product Code
LPH, KWZ, HWC, MEH, LZO, KWY, LWJ, MBL, MAY, KWL, JDI
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3358, 888.3310, 888.3040, 888.3353, 888.3390, 888.3360, 888.3350
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

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