Duns Number:187560545
Device Description: DBX Mix, 20cc
Catalog Number
058200
Brand Name
DBX®
Version/Model Number
058200
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
39468716-1cfb-481f-9a81-bf0be5845c47
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |