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IlluminOss CT-0186

by IlluminOss Medical

Ref CT-0186

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

CE MDR De Novo

Valid until

No date given

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

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

De Novo DEN160062

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++M986FLEXTUBES9L Basic UDI-DI M986CT01860UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberM986CT01860 UDI-DI Date28 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG GUDID from GUDID De Novo granted · Direct NumberDEN160062 Date19 Dec 2017DecidedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA De Novo Active

Specification

EUDAMED · GUDID

Trade name
IlluminOss Reusable Instruments EUDAMED
IlluminOss GUDID
Generic name
Orthopaedic bone pin, non-bioabsorbable
Device name
Class 1r & 1m Reusable Surgical Instruments
Model / Ref / Catalog
CT-0186
Primary DI / UDI-DI
M986CT01860
Basic UDI-DI
++M986FLEXTUBES9L
Direct marketing DI
+M986CT01860D
De Novo Number
FDA product code
QAD, LXH
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3023, 888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (DEN160062)

Show all (12)

Other devices from IlluminOss Medical

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Properties

  • Sterilise before use
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number

Other properties (19)

  • Supplied sterile: No
  • Single use: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: 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