Catalog Number
-
Brand Name
Nexadental
Version/Model Number
Mega 3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
bdc3c677-482b-462f-899b-761612c68372
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
Package DI Number
40868258000238
Quantity per Package
4
Contains DI Package
10868258000237
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case