Identity
- Trade Name
- Licox® FDA UDI
- Generic Name
- Neurosurgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Licox® Brain Tissue Oxygen Monitoring- Single Lumen Introducer Kit FDA UDI
- Model / Reference
- IM1 FDA UDI
- Description
- Licox® Brain Tissue Oxygen Monitoring- Single Lumen Introducer Kit FDA UDI
Identifiers
- Catalog Number
- IM1 FDA UDI
- Primary DI / UDI-DI
- 10381780250203 FDA UDI
- 510(k) Number
- K002765 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Neurosurgical procedure kit, non-medicated, single-use 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: Neurosurgical procedure kit, non-medicated, single-use
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 Neurosurgical procedure kit, non-medicated, single-use.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra LifeSciences Switzerland Sàrl
Sources (1)
- FDA UDI d42a64e8-24eb-412c-b5ea-8646971919fc 37 fields · synced Jun 6, 2026