Catalog Number

21302

Brand Name

Osseofix

Version/Model Number

21302

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2020

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

-

Product Code

JDZ

Product Code Name

Mixer, Cement, For Clinical Use

Public Device Record Key

5ed16262-1181-4b11-bb73-de1aed92a370

Public Version Date

December 15, 2020

Public Version Number

2

DI Record Publish Date

September 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-