Identity
- Trade Name
- Cement Separator FDA UDI
- Generic Name
- Bone curette, reusable FDA UDI
- Device Name
- Reverse Curette, 7mm EUDAMEDCement Separator FDA UDI
- Model / Reference
- 10-248-400 EUDAMEDFDA UDI
- Description
- Cement Separator FDA UDI
Identifiers
- Catalog Number
- 2500-00-761 FDA UDI
- Primary DI / UDI-DI
- 00847538007923 EUDAMEDFDA UDI
- Basic UDI-DI
- 08475380477354S EUDAMED
- Direct Marketing DI
- 00847538007923 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091105 CEMENTATION INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Bone curette, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Bone-screw internal spinal fixation system, sterile
Reverse Curette, 7mm by Symmetry Medical Manufacturing, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08475380477354S | 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 2a56a020-944b-4274-b161-7c54d9604d8a 61 fields · synced Oct 6, 2026
- FDA UDI 3e30f4cc-34c1-4c5b-8491-2bae5ff17533 34 fields · synced May 30, 2026