Licox®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Switzerland Sàrl

Identity

Trade Name: Licox® FDA UDI
Generic Name: Intracerebral sensor catheter, short-term FDA UDI
Device Name: Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit FDA UDI
Model / Reference: IT2 FDA UDI
Description: Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit FDA UDI

Identifiers

Catalog Number: IT2 FDA UDI
Primary DI / UDI-DI: 10381780250340 FDA UDI
510(k) Number: K053244 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional 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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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 f15b27b3-dcf4-491f-b520-c94af26b547b 37 fields · synced Jun 8, 2026