AccessGUDID - DEVICE: Licox® (10381780250340)

GUDID

Device Identifier (DI) Information

Brand Name: Licox®
Version or Model: IT2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IT2
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780250340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use
Previous DI: 10381780041207

Device Description: Licox® Brain Tissue Oxygen Monitoring- Complete Brain Tunnelling Probe Kit

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61398	Intracerebral sensor catheter, short-term	A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053244	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Special Storage Condition, Specify: Do Not Use if Package is Damaged; Keep Away From Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f15b27b3-dcf4-491f-b520-c94af26b547b
Public Version Date: May 16, 2023
Public Version Number: 11
DI Record Publish Date: August 04, 2016