Catalog Number

BCT00CT

Brand Name

AVAmax

Version/Model Number

BCT00CT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2017

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"

Yes

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

00fb64c0-99e0-45e2-b35b-c4fa917b267f

Public Version Date

November 13, 2019

Public Version Number

3

DI Record Publish Date

June 12, 2017

Package DI Number

50885403002098

Quantity per Package

5

Contains DI Package

10885403002090

Package Discontinue Date

August 30, 2017

Package Status

Not in Commercial Distribution

Package Type

Case