AccessGUDID - DEVICE: Licox® (10381780250111)

GUDID

Device Identifier (DI) Information

Brand Name: Licox®
Version or Model: BC10R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BC10R
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780250111
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use
Previous DI: 10381780041245

Device Description: Licox® Probe test set

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
36798	Transistor tester	An electronic instrument designed to test the electrical performance of transistors and solid-state diodes to provide verification of their ability to function. It is typically used by biomedical service personnel involved in the repair, servicing, and maintenance of electrical medical devices. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002765	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b034aa9d-df3c-4f3e-a8ef-ed80a96bd73e
Public Version Date: May 12, 2023
Public Version Number: 8
DI Record Publish Date: August 02, 2016