Catalog Number

-

Brand Name

A-Oss®

Version/Model Number

AOSN010SV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151542

Product Code

NPM

Product Code Name

Bone Grafting Material, Animal Source

Public Device Record Key

dcead1f6-4eac-4b82-b7af-e4b403e3ea03

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-