Identity
- Trade Name
- NVJJB FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- NVJJB Insulator, InStim K-Wire Sterile FDA UDI
- Model / Reference
- 1010346 FDA UDI
- Description
- NVJJB Insulator, InStim K-Wire Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517061799 FDA UDI
- 510(k) Number
- K112709 FDA UDI
- FDA Product Code
- ETN 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neurophysiologic monitoring system
Nvjjb by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112709 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
- Nuvasive, Inc.
Sources (1)
- FDA UDI f64df5b2-51f1-4b1c-bacb-d94f8a2ee94c 35 fields · synced May 31, 2026