Catalog Number

-

Brand Name

Cranial LOOP

Version/Model Number

FC050000

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

K132044,K132044,K132044,K132044

Product Code

GXR

Product Code Name

Cover, Burr Hole

Public Device Record Key

7ded4938-0c7f-4805-a250-c9b981e4334d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 08, 2015

Package DI Number

48437006085043

Quantity per Package

10

Contains DI Package

38437006085046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-