Duns Number:083235549
Device Description: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple)
Catalog Number
603015
Brand Name
Megalloy®EZ Spherical Amalgam
Version/Model Number
603015
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
FDA Premarket Submission
-
Product Code
EJJ
Product Code Name
Alloy, amalgam
Public Device Record Key
2f2b609f-6b70-4d8b-808c-506b7208e1eb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
D0026030152
Quantity per Package
4
Contains DI Package
D0026030151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 123 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 397 |
| U | Unclassified | 2 |