Identity
- Trade Name
- LimiTorr™ FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- The Pole Mount Laser Level device is provided with mounting bracket for use with Integra Pole Mount Assemblies. The Pole Mount Laser provides alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular catheter or lumbar catheter to an external ventricular drainage system. FDA UDI
- Model / Reference
- INS400L FDA UDI
- Description
- The Pole Mount Laser Level device is provided with mounting bracket for use with Integra Pole Mount Assemblies. The Pole Mount Laser provides alignment for the External CSF Drainage and Monitoring Systems. These systems are used for draining CSF from an intraventricular catheter or lumbar catheter to an external ventricular drainage system. FDA UDI
Identifiers
- Catalog Number
- INS400L FDA UDI
- Primary DI / UDI-DI
- 10381780112228 FDA UDI
- 510(k) Number
- K062599 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventricular cerebrospinal fluid drainage catheterization kit 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Ventricular cerebrospinal fluid drainage catheterization kit
LimiTorr™ by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.
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Cleared under the same submission
K062599 also covers:
- BioPatch® — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
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 bb15d656-6374-4047-b9c8-04a24db7ae99 37 fields · synced Jun 8, 2026