Identity
- Trade Name
- SPiN Thoracic Navigation System, 120V, 60Hz FDA UDI
- Generic Name
- Electromagnetic surgical navigation device tracking system FDA UDI
- Model / Reference
- SYS-4000 FDA UDI
Identifiers
- Catalog Number
- SYS-4000 FDA UDI
- Primary DI / UDI-DI
- 00815686020101 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Electromagnetic surgical navigation device tracking system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SPiN Thoracic Navigation System, 120V, 60Hz by Veran Medical Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Veran Medical Technologies Inc.
Sources (1)
- FDA UDI c906606c-fe70-4040-9317-e48c852961a1 34 fields · synced May 30, 2026