Catalog Number

048025

Brand Name

DBX®

Version/Model Number

048025

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 2019

Issuing Agency

In ICCBBA

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

940a458e-1c3a-477c-be82-4f3118487865

Public Version Date

June 13, 2019

Public Version Number

3

DI Record Publish Date

February 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-