Catalog Number

BCPM003

Brand Name

AVAtex

Version/Model Number

BCPM003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 18, 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

064aadf4-2604-458b-9ddd-db0266ab0a7d

Public Version Date

November 12, 2019

Public Version Number

3

DI Record Publish Date

June 12, 2017

Package DI Number

50885403002067

Quantity per Package

5

Contains DI Package

10885403002069

Package Discontinue Date

July 18, 2017

Package Status

Not in Commercial Distribution

Package Type

Case