Catalog Number

5091001

Brand Name

NuOss

Version/Model Number

5091001

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

NPM

Product Code Name

BONE GRAFTING MATERIAL, ANIMAL SOURCE

Public Device Record Key

c161ab5c-aa11-4569-9fce-4d495d91e361

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-