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Symphony Oct System

by Medos International SARL EUDAMEDGUDID

Active European Union

Ref 2020-00-120Model SYMPHONY Navigation Ready Instruments Surgical Navigation Instrument

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705034a000145F Basic UDI-DIDate24 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10705034530420 UDI-DIDate22 May 2019ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Symphony Oct System EUDAMED
Symphony GUDID
Generic Name
Surgical drill guide, reusable
Device Name
SYMPHONY Navigation Ready Drill Guide Body Drill Trocar Probe Tap Screw Driver Sleeve
Model / Ref / Catalog
SYMPHONY Navigation Ready Instruments Surgical Navigation Instrument, 2020-00-120, 202000120
Primary DI / UDI-DI
10705034530420
Basic UDI-DI
0705034a000145F
Direct Marketing DI
10705034530420
510(k) Number
FDA Product Code
OLO, FZX
EMDN Code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN Term
Surgical drill guide, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560, 878.4800
Market of Registration
Belgium
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

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
  • 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