COAPTIUM® Selector - NCOSE0001
2025-10-03
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015546200 | 3015546200 | TISSIUM SA | 1 | N | 2026-01-01 | TISSIUM F1 Manufacturing Site Parc Activite Pierre Mauroy, 2 rue Pierre Antoin Roncq Nord FR 59223 |
| 3032948633 | 3032948633 | TISSIUM Inc | 1 | Y | 2026-01-01 | 245 Main St 2nd Floor Cambridge MA US 02142 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03760279380070 | COAPTIUM® Connect - Sutureless Nerve Coaptation SystemCOAPTIUM® 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. | 1.888.847.7486 | customercare@tissium.com |
| 03760279380087 | COAPTIUM® Connect - Sutureless Nerve Coaptation SystemCOAPTIUM® 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. | 1.888.847.7486 | customercare@tissium.com |
| 03760279380094 | COAPTIUM® Connect - Sutureless Nerve Coaptation SystemCOAPTIUM® 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. | 1.888.847.7486 | customercare@tissium.com |
| 03760279380100 | COAPTIUM® Connect - Sutureless Nerve Coaptation SystemCOAPTIUM® 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. | 1.888.847.7486 | customercare@tissium.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341637 | 1137281249 | DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | SFD | 2025-06-17 |
| 341637 | 1135947613 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SFD | 1 | 2025-06-17 |
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