Catalog Number

-

Brand Name

Axograft DBM Putty 0.5cc - Jar

Version/Model Number

X090-0015-PT0.5CCJ

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

FDA Premarket Submission

K130498

Product Code

MBP

Product Code Name

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Public Device Record Key

889a83ec-7153-4bd5-96d0-26ac5540d4e8

Public Version Date

June 16, 2021

Public Version Number

4

DI Record Publish Date

November 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-