Catalog Number

PMOFC

Brand Name

Licox®

Version/Model Number

PMOFC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 29, 2020

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040235

Product Code

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Public Device Record Key

546108da-0ec7-41a6-825c-40771c74e36a

Public Version Date

June 10, 2020

Public Version Number

4

DI Record Publish Date

October 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-