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Symphony Oct System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2020-00-101Model SYMPHONY OCT INSTRUMENTS - CUTTING INSTRUMENTS
Identity
- Trade Name
- SYMPHONY OCT SYSTEM EUDAMEDSYMPHONY FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- ORTHOPAEDIC SURGERY, CUTTING INSTRUMENTS - OTHERS - SYMPHONY OCT INSTRUMENTS EUDAMEDSYMPHONY OCT SYSTEM AWL 2.0mm FDA UDI
- Model / Reference
- SYMPHONY OCT INSTRUMENTS - CUTTING INSTRUMENTS EUDAMED2020-00-101 EUDAMEDFDA UDI
- Description
- SYMPHONY OCT SYSTEM AWL 2.0mm FDA UDI
Identifiers
- Catalog Number
- 202000101 FDA UDI
- Primary DI / UDI-DI
- 10705034530291 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002015G EUDAMED
- Direct Marketing DI
- 10705034530291 EUDAMED
- FDA Product Code
- HWJ FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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: Bone cutting forceps, reusable
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 | 0705034a002015G | 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 cec3c6f2-c16e-4cea-a65d-404292138d4b 61 fields · synced Jul 31, 2026
- FDA UDI 191cdf8a-b590-43d6-9aa1-c3b3249aeeea 35 fields · synced May 30, 2026