Catalog Number

-

Brand Name

N/A

Version/Model Number

9013 A

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

K833822

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

f12a21ce-c775-4149-a1e7-2d510023084d

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-