Catalog Number

MX-1100S

Brand Name

StabiliT MX Fracture Kit

Version/Model Number

MX-1100L-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 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

NDN

Product Code Name

Cement, Bone, Vertebroplasty

Public Device Record Key

358b9564-ca2a-4a7e-a091-63012360daea

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

November 30, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-