Catalog Number

227007

Brand Name

DBX

Version/Model Number

227007

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

f6a71121-de23-42d6-a400-9dd10c5627a6

Public Version Date

July 02, 2019

Public Version Number

1

DI Record Publish Date

June 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-