Integra®
- Primary DI
- 10381780024460
- Brand
- Integra®
- Company
- Integra Lifesciences Corporation
- Model
- NL97005S01
- Catalog number
- NL97005S01
- Device description
- 5 FRENCH T-TUBEThe 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.
- Published
- 2015-09-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| JXG | Shunt, central nervous system and components |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K854049 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780024460 | Primary | GS1 | 0 | |
| M269NL97005S011 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780024460 | 10381780024460 |
GMDN Terms#
| Term | Definition |
|---|---|
| Lumboperitoneal shunt | A sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity, where it can be absorbed into the body, as a treatment for elevated intracranial pressure due to increased CSF. It typically consists of fully-implanted interconnected components that include a spinal catheter implanted into the subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a reservoir which can be punctured for sampling/infusion; and a peritoneal catheter implanted into the peritoneal cavity. Disposable devices associated with implantation may be included. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 083171244
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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