Duns Number:256880576
Device Description: DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE
Catalog Number
1016-ST30
Brand Name
MEDICOM DURAFLOR ULTRA
Version/Model Number
1016-ST30
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"
Yes
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
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
433222e4-74ba-498d-90a9-4270d50feec8
Public Version Date
April 19, 2022
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
20686864040983
Quantity per Package
6
Contains DI Package
10686864040986
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |