Identity
- Trade Name
- Chisel, 8mm FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Flag Splitter EUDAMEDChisel, 8mm FDA UDI
- Model / Reference
- 10-003-400 EUDAMEDFDA UDI
- Description
- Chisel, 8mm FDA UDI
Identifiers
- Catalog Number
- 2709-01-008 FDA UDI
- Primary DI / UDI-DI
- 00847538006353 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380108252A EUDAMED
- Direct Marketing DI
- 00847538006353 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090402 ORTHOPAEDIC SURGERY SCALPELS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Flag Splitter by Symmetry Medical Manufacturing, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08475380108252A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Medical Manufacturing, Inc.
- EUDAMED SRN
- US-MF-000025394
- Authorised Representative
- SYMMETRY MEDICAL POLYVAC FR-AR-000003187
Sources (2)
- EUDAMED d8fc38e2-8bbe-4943-85ee-8539cbec5a82 61 fields · synced Oct 6, 2026
- FDA UDI 6d4bee88-1338-4189-a363-d5db690a3c01 34 fields · synced May 30, 2026