Identity
- Trade Name
- Calibration Device EUDAMEDMulti-Tool Calibration Device FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Standard Pointer EUDAMED
- Model / Reference
- SYN-0642 EUDAMEDSYN-0755 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000252 EUDAMEDFDA UDI
- Basic UDI-DI
- 67008200005LR EUDAMED
- Direct Marketing DI
- 00670082000252 EUDAMED
- 510(k) Number
- K183325 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- L031199 PROBES AND MIRRORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Calibration Device by Synaptive Medical 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 | 67008200005LR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Synaptive Medical Inc.
- EUDAMED SRN
- CA-MF-000010705
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 428309ec-1d0c-4d43-b1c7-04dbb95a9bbb 61 fields · synced Jul 25, 2026
- FDA UDI 40faea72-e4fc-42d1-88ae-c02d24f12803 33 fields · synced May 30, 2026