Identity
- Trade Name
- MoniTorr ICP™ FDA UDI
- Generic Name
- Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- The MoniTorr ICP External CSF Drainage and Monitoring System is designed to provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF), and allows for accurate pressure and flow rate monitoring. The system may be used with a pole mounted assembly that provides simple, quick, and accurate alignment with the patient and secure, accurate positive or negative pressure head setting. FDA UDI
- Model / Reference
- 10110A FDA UDI
- Description
- The MoniTorr ICP External CSF Drainage and Monitoring System is designed to provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF), and allows for accurate pressure and flow rate monitoring. The system may be used with a pole mounted assembly that provides simple, quick, and accurate alignment with the patient and secure, accurate positive or negative pressure head setting. FDA UDI
Identifiers
- Catalog Number
- 10110A FDA UDI
- Primary DI / UDI-DI
- 10381780070856 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Lumbar 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit
MoniTorr ICP™ 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
K022554 also covers:
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve — Integra Lifesciences Corp.
- MoniTorr ICP™ External CSF Drainage System — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
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.
- LimiTorr™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
K191684 also covers:
- LimiTorr™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ External CSF Drainage System — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
K920156 also covers:
- Integra™ Pole Mount Spare Parts Kit — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve — Integra Lifesciences Corp.
- MoniTorr ICP™ External CSF Drainage System — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — 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 9d77d3d1-1eba-47b5-a5ab-ccf044595420 37 fields · synced May 30, 2026