Catalog Number

9MZ500

Brand Name

Radiopaque Polypropylene Plug

Version/Model Number

9MZ500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K955832

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Public Device Record Key

db81d05c-c054-4c2f-8ef0-e9696a9fa066

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-