Catalog Number

-

Brand Name

SMARTGRAFT Granules

Version/Model Number

0114.103

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

dfc052da-d63e-4131-a3bd-3f5570b96e17

Public Version Date

October 13, 2020

Public Version Number

1

DI Record Publish Date

October 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-