Catalog Number

137630000

Brand Name

CEMENTRALIZER

Version/Model Number

1376-30-000

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

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

K871510

Product Code

JDK

Product Code Name

Prosthesis, hip, cement restrictor

Public Device Record Key

425c6aea-9dde-4efd-9113-834ca606e3b4

Public Version Date

September 17, 2020

Public Version Number

4

DI Record Publish Date

March 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-