Identity
- Trade Name
- SafeOp FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- SafeOp Insulated Dilator Kit, Sterile FDA UDI
- Model / Reference
- AIX1330-S FDA UDI
- Description
- SafeOp Insulated Dilator Kit, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190376232300 FDA UDI
- 510(k) Number
- K191723 FDA UDI
- FDA Product Code
- PDQ FDA UDIETN FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
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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Cleared under the same submission
K191723 also covers:
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 25404ed1-900b-401b-b24e-448e405f7b2d 35 fields · synced Jun 8, 2026