Duns Number:825137818
Device Description: 5% SODIUM FL VARNISH CARAMEL DARBY
Catalog Number
9510058
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9510058
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2018
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)
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
60c511f2-e912-40a1-8747-f566aba0bda9
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
March 24, 2018
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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |