Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Lumboperitoneal shunt FDA UDI
- Device Name
- 3 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide continuous drainage of fluid from within a spinal cord cyst to a site outside the spinal canal. The T-tube diameter is small to minimize the size of the myelotomy and the catheter is flexible to minimize the spinal cord manipulation necessary to insert the tube into a spinal cord cyst. The T-shape allows drainage above and below the myelotomy site, helps prevent kinking by providing a right-angle exit through the dura, and reduces the risk of migration out of the spinal cord. The multi-holed catheter reduces the risk of clogging at the spinal end of the system. The suture tab allows the T-tube to be anchored to the dura or paraspinous muscles without the risk of shunt occlusion associated with a circumferential ligature. If a step down connector is used, it adapts the T-tube diameter to the peritoneal reflux control catheter. FDA UDI
- Model / Reference
- NL97003S01 FDA UDI
- Description
- 3 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide continuous drainage of fluid from within a spinal cord cyst to a site outside the spinal canal. The T-tube diameter is small to minimize the size of the myelotomy and the catheter is flexible to minimize the spinal cord manipulation necessary to insert the tube into a spinal cord cyst. The T-shape allows drainage above and below the myelotomy site, helps prevent kinking by providing a right-angle exit through the dura, and reduces the risk of migration out of the spinal cord. The multi-holed catheter reduces the risk of clogging at the spinal end of the system. The suture tab allows the T-tube to be anchored to the dura or paraspinous muscles without the risk of shunt occlusion associated with a circumferential ligature. If a step down connector is used, it adapts the T-tube diameter to the peritoneal reflux control catheter. FDA UDI
Identifiers
- Catalog Number
- NL97003S01 FDA UDI
- Primary DI / UDI-DI
- 10381780072522 FDA UDI
- 510(k) Number
- K854049 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Lumboperitoneal shunt FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
Category: Lumboperitoneal shunt
Integra® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K854049 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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI 4183c4ea-b269-41bd-ac84-de827d8347e2 37 fields · synced May 29, 2026