Identity
- Trade Name
- Rebuilder Nerve Guidance Conduit FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Model / Reference
- TG-060 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975222390069 FDA UDI
- 510(k) Number
- K230794 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbable
Rebuilder Nerve Guidance Conduit by Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Nerve guide, synthetic polymer, bioabsorbable.
- COAPTIUM® Connect — Tissium SA · Class II
- Neurolac — Polyganics Innovations B.V. · Class II
- VersaWrap — ALAFAIR BIOSCIENCES, INC. · Class II
- COAPTIUM® Connect — Tissium SA · Class II
- Neurolac TW — Polyganics Innovations B.V. · Class II
- Neurolac — Polyganics Innovations B.V. · Class II
- COAPTIUM® Connect — Tissium SA · Class II
- Neurolac — Polyganics Innovations B.V. · Class II
Cleared under the same submission
K230794 also covers:
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
- Rebuilder Nerve Guidance Conduit — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.
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
Sources (1)
- FDA UDI 5910c50f-3e1f-477b-9395-51fcfe168127 33 fields · synced May 30, 2026