Catalog Number

BC10TV

Brand Name

Licox®

Version/Model Number

BC10TV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 02, 2016

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

-

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

K002765

Product Code

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Public Device Record Key

e87c94cf-3f97-48dd-8abb-c6f01f6672b3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-