Identity
- Trade Name
- Neurotube FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction. FDA UDI
- Model / Reference
- GEM0240NT FDA UDI
- Description
- The NEUROTUBE device Absorbable Woven Polyglycolic Acid Mesh Tube is designed for primary or secondary peripheral nerve repair or reconstruction. FDA UDI
Identifiers
- Catalog Number
- 531101240011 FDA UDI
- Primary DI / UDI-DI
- 00844735006186 FDA UDI
- 510(k) Number
- K983007 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 40 Millimeter FDA UDILumen/Inner Diameter — 2.3 Millimeter FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbable
Neurotube by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983007 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
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI dcec7274-2d51-48f2-af50-a139b2b3ed6b 37 fields · synced Jun 1, 2026