Catalog Number

-

Brand Name

DJO SURGICAL

Version/Model Number

600-10-100

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LOD

Product Code Name

BONE CEMENT

Public Device Record Key

4024c730-061f-400a-ae5c-c33d7f5aaba0

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-