Catalog Number

82-8851

Brand Name

CODMAN CERTAS®

Version/Model Number

828851

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K143111

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

248f1fc6-a054-4ac6-ac48-dc2a87672d7b

Public Version Date

October 03, 2022

Public Version Number

5

DI Record Publish Date

February 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-