Catalog Number

038005

Brand Name

DBX®

Version/Model Number

038005

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"

-

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

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Public Device Record Key

a4207896-01a2-4b4b-8be4-33a58c4d16bf

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-