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Symphony Oct System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2020-00-128Model SYMPHONY OCT INSTRUMENTS - INSTRUMENTS FOR INSERTION AND EXTRACTION
Identity
- Trade Name
- SYMPHONY OCT SYSTEM EUDAMEDSYMPHONY FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- INSTRUMENTS FOR INSERTION AND EXTRACTION OF OSTEOSYNTHESIS DEVICES - SYMPHONY OCT INSTRUMENTS EUDAMEDSYMPHONY OCT SYSTEM DRILL GUIDE BODY FIXED 12MM FDA UDI
- Model / Reference
- SYMPHONY OCT INSTRUMENTS - INSTRUMENTS FOR INSERTION AND EXTRACTION EUDAMED2020-00-128 EUDAMEDFDA UDI
- Description
- SYMPHONY OCT SYSTEM DRILL GUIDE BODY FIXED 12MM FDA UDI
Identifiers
- Catalog Number
- 202000128 FDA UDI
- Primary DI / UDI-DI
- 10705034530468 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002025J EUDAMED
- Direct Marketing DI
- 10705034530468 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wire holding/twisting forceps
Symphony Oct System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002025J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 26f89893-b30a-44b2-849f-a8178a841c64 61 fields · synced Jul 9, 2026
- FDA UDI 6a57b0fe-9f48-47b1-9462-ab35a43236e0 35 fields · synced May 30, 2026