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Flexible Reamers System 1

by Orthofix, Inc.

Ref 172002Model Accessory

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 Number805050436Accssry1NA3Q Basic UDI-DI 18059015378368UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18059015378368 UDI-DI Date23 Jul 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  • Withdrawn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
Flexible Reamer EUDAMED
Flexible Reamers System GUDID
Generic Name
Instrument tray, reusable
Model / Ref / Catalog
Accessory, 172002, 1
Primary DI / UDI-DI
18059015378368
Basic UDI-DI
805050436Accssry1NA3Q
FDA Product Code
FSM
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Instrument tray, reusable
Device Class
Class I
Regulation Number
878.4800
Market of Registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Accessory
172002
GUDID
1

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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