Catalog Number

-

Brand Name

Strata®

Version/Model Number

46866

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

K060681

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

e1c01d43-2dc8-4ed1-a94a-3e27904aa9d7

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

March 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-