Catalog Number

-

Brand Name

Profiniti Bioactive

Version/Model Number

AFMS020

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"

-

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

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

6d2ea990-45f3-499b-bf81-6c5bbbbc6145

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-