Identity
- Trade Name
- COAPTIUM® Connect FDA UDI
- Generic Name
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
- Device Name
- Sutureless Nerve Coaptation System COAPTIUM® CONNECT is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury. FDA UDI
- Model / Reference
- NCOCO3015 FDA UDI
- Description
- Sutureless Nerve Coaptation System COAPTIUM® CONNECT is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury. FDA UDI
Identifiers
- Catalog Number
- NCOCO3015 FDA UDI
- Primary DI / UDI-DI
- 03760279380124 FDA UDI
- FDA Product Code
- SFD FDA UDI
- GMDN Term
- Nerve guide, synthetic polymer, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5270 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
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Millimeter FDA UDILength — 15 Millimeter FDA UDI
Category: Nerve guide, synthetic polymer, bioabsorbable
COAPTIUM® Connect by Tissium SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Tissium SA
Sources (1)
- FDA UDI d30086ff-618c-4af8-aaf1-785dd98d75da 37 fields · synced Jun 6, 2026