Catalog Number

-

Brand Name

N/A

Version/Model Number

25077

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

K831396

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

401a9777-e85a-490a-895d-668bd9bfd607

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-