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Mitek Cruciate+

by Medos International SARL 2 variants

Ref 215203, 219018, 219004, 219006, 219005, 219011, 219013, 219003Model Cleaning Sterilization and Disinfection Instruments, Ligament Reconstruction Sets, CRUCIATE+ Ligament Reconstruction Sets

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 Number0886705a00004JX Basic UDI-DI Date30 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10886705025749 UDI-DI Date20 Apr 2017ListedStatusListed 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  • Withdrawn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

Generic Name
Ligament reconstruction instrument set, reusable
Instrument tray, reusable
Device Name
Sterilization Instrument
CRUCIATE+ Suture Passing Pin, Bullet, Point, Capture, Tibial, Femoral, Disc, Rasp, Elevator, Depth Gage, ACL, PCL
CRUCIATE+ Guide Carriage, Obturator, Bullet Insert
Model / Ref / Catalog
Cleaning Sterilization and Disinfection Instruments, 215203, 219013, 219011, 219003, 219006, 219018, 219005, 219004, Ligament Reconstruction Sets, CRUCIATE+ Ligament Reconstruction Sets
Primary DI / UDI-DI
10886705025749, 10886705025695, 10886705025718, 10886705025855, 10886705025787, 10886705025664, 10886705025794, 10886705025831
Basic UDI-DI
0886705a00004JX, 0886705a00145KJ, 0886705a00154KK
Direct Marketing DI
10886705025749
10886705025664
10886705025831
10886705025787
10886705025794
10886705025718
10886705025695
10886705025855
FDA Product Code
LXH, FSM
EMDN Code
Z12011380, L0999, L1920
GMDN Term
Ligament reconstruction instrument set, reusable
Instrument tray, reusable
Device Class
Class I
Regulation Number
888.4540, 878.4800
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Reusable NoEUDAMEDYesEUDAMED
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Measuring Function NoEUDAMEDYesEUDAMED
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (18)

  • 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No