Identity
- Trade Name
- Licox® FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- Licox® Brain Tissue Oxygen Monitoring-Temperature Probe FDA UDI
- Model / Reference
- C8B FDA UDI
- Description
- Licox® Brain Tissue Oxygen Monitoring-Temperature Probe FDA UDI
Identifiers
- Catalog Number
- C8B FDA UDI
- Primary DI / UDI-DI
- 10381780250159 FDA UDI
- 510(k) Number
- K002765 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracerebral sensor catheter, short-term FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 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
Yes
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
Yes
FDA UDI
Category: Intracerebral sensor catheter, short-term
Licox® by Integra LifeSciences Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intracerebral sensor catheter, short-term.
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- IRRAflow® Drainage Collection System — Irras USA · Class II
- NEUROVENT-TEMP-IFD-R — RAUMEDIC AG · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- NEUROVENT-P-TEMP — RAUMEDIC AG · Class II
Cleared under the same submission
K002765 also covers:
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Licox® — Integra LifeSciences Switzerland Sàrl
- Licox® — Integra LifeSciences Switzerland Sàrl
- Licox® — Integra LifeSciences Switzerland Sàrl
- Licox® — Integra LifeSciences Switzerland Sàrl
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 Switzerland Sàrl
Sources (1)
- FDA UDI 2f332cf0-d32d-479b-9e9f-c22a52aa80d3 37 fields · synced May 30, 2026