Duns Number:364004762
Device Description: ACR MON #3 SC (QT EACH)
Catalog Number
3830030
Brand Name
Axcent Acrylics
Version/Model Number
3830030
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
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
3a7ed16a-9168-4744-849f-2721d643ebd4
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
September 25, 2016
Package DI Number
D79338300301
Quantity per Package
4
Contains DI Package
D79338300300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 134 |