Identity
- Trade Name
- NEUROCAP FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Model / Reference
- 6.0 mm FDA UDI
Identifiers
- Catalog Number
- NC01-060/03 FDA UDI
- Primary DI / UDI-DI
- 08717703990294 FDA UDI
- 510(k) Number
- K152684 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
MR Safe FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbable
Neurocap by Polyganics Innovations B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve guide, synthetic polymer, bioabsorbable.
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- VersaWrap — ALAFAIR BIOSCIENCES, INC. · Class II
- COAPTIUM® Connect — Tissium SA · Class II
- COAPTIUM® Connect — Tissium SA · Class II
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. · Class II
- Neurotube — SYNOVIS MICRO COMPANIES ALLIANCE, INC · Class II
- allay™ Nerve Cap - Large Nerve Set — TULAVI THERAPEUTICS · Class II
Cleared under the same submission
K152684 also covers:
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
- NEUROCAP — Polyganics Innovations B.V.
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
- Polyganics Innovations B.V.
Sources (1)
- FDA UDI edc223cb-d050-476b-b1b3-81c2ba68a794 36 fields · synced May 30, 2026