Catalog Number

AFB1015

Brand Name

AVAflex

Version/Model Number

AFB1015

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

NDN

Product Code Name

Cement, Bone, Vertebroplasty

Public Device Record Key

780cac7a-2bbb-4181-95c2-c122e7045e74

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2015

Package DI Number

50885403223257

Quantity per Package

5

Contains DI Package

10885403223259

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS