Catalog Number

AFH0010

Brand Name

AVAflex

Version/Model Number

AFH0010

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"

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

OAR

Product Code Name

Injector, Vertebroplasty (Does Not Contain Cement)

Public Device Record Key

3dfd8821-a571-4ba0-8a7e-06278c0d2df1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 12, 2017

Package DI Number

50885403219786

Quantity per Package

5

Contains DI Package

10885403219788

Package Discontinue Date

-

Package Status

-

Package Type

Case