Catalog Number

-

Brand Name

GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)

Version/Model Number

P42210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 11, 2016

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

K051195

Product Code

MBP

Product Code Name

Filler, bone void, osteoinduction (w/o human growth factor)

Public Device Record Key

3437e3be-6205-4ae8-b40a-c1cc3ef58f45

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-