Catalog Number

-

Brand Name

Strata™

Version/Model Number

44465

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K123524

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

4caf95da-bea0-4281-a711-9129ce3c892d

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-