Catalog Number

-

Brand Name

AttraX

Version/Model Number

5015010

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

K151584

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Public Device Record Key

627b310e-ecdf-45ba-8f63-93032bd2de1a

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

March 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-