Identity
- Trade Name
- SafeOp FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- SafeOp Neural Informatix System Cable, Left stimulator (Blue) FDA UDI
- Model / Reference
- 100831 FDA UDI
- Description
- SafeOp Neural Informatix System Cable, Left stimulator (Blue) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376218809 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurophysiologic monitoring system
SafeOp by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 6ded9e92-43bb-4f26-acb1-ed00c83a132c 34 fields · synced Jun 8, 2026