Identity
- Trade Name
- Neurolac FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Model / Reference
- 8.0 mm FDA UDI
Identifiers
- Catalog Number
- NG01-080/03 FDA UDI
- Primary DI / UDI-DI
- 08717703990171 FDA UDI
- 510(k) Number
- K050573 FDA UDI
- FDA Product Code
- JXI FDA UDI
- GMDN Term
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 8 Millimeter FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbable
Neurolac by Polyganics Innovations B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Polyganics Innovations B.V.
Sources (1)
- FDA UDI 32c85c4f-2f3f-4c53-9d0a-3da178f2d3c3 37 fields · synced Jun 8, 2026