Catalog Number

-

Brand Name

NA

Version/Model Number

27553 L

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

K951258

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

597aa2a3-a163-4f3e-b9db-e4c45d0b6acf

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-