Identity
- Trade Name
- Long Flat Osteotome Blade FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- “X” Osteotome, 7mm EUDAMEDLong Flat Osteotome Blade FDA UDI
- Model / Reference
- 11-130-001 EUDAMEDFDA UDI
- Description
- Long Flat Osteotome Blade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847538009347 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380128442U EUDAMED
- Direct Marketing DI
- 00847538009347 EUDAMED
- FDA Product Code
- GFI FDA UDI
- EMDN Code
- L090404 OSTEOTOMES AND SCALPELS BLADES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
“X” Osteotome, 7mm 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 | 08475380128442U | 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 6b3f59eb-ed05-4667-9fa7-a320e04eb755 61 fields · synced Jul 9, 2026
- FDA UDI 1badecd4-8fff-4d77-bc95-a1d498d177db 33 fields · synced May 29, 2026