Catalog Number

1688

Brand Name

StabiliT ER2 Bone Cement and Saturate Mixing System

Version/Model Number

1688

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

d5319d48-1cc5-4e52-97c1-a9698541608a

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

December 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-