Catalog Number

-

Brand Name

alloOss Allograft Putty

Version/Model Number

01105002

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)

Yes

FDA Premarket Submission

-

Product Code

MBP

Product Code Name

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

Public Device Record Key

ed5e9426-2aac-4486-9b06-0bf717ab2911

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-