Catalog Number

82-8859

Brand Name

CODMAN CERTAS®

Version/Model Number

828859

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

-

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,K143111

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

9bd86e5a-8c5d-4c36-b5eb-a978ce583f22

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

-