Catalog Number

-

Brand Name

Cranial COVER “14 mm / 13 mm”

Version/Model Number

FC050300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K160739,K160739

Product Code

GXR

Product Code Name

Cover, Burr Hole

Public Device Record Key

8103ff2b-2484-41cb-a7c7-de3accf79977

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 11, 2017

Package DI Number

28437006085070

Quantity per Package

64

Contains DI Package

08437006085076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-