Duns Number:006309355
Device Description: Young D-Lish EZ-Paks - Classic DPA & Latex Free, Soft, Short, Traditional Web Purple Cup & Young D-Lish EZ-Paks - Classic DPA & Latex Free, Soft, Short, Traditional Web Purple Cup & D-Lish Mint, Course Grit
Catalog Number
320010
Brand Name
Young
Version/Model Number
320010
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
EGS
Product Code Name
Handpiece, contra- and right-angle attachment, dental
Public Device Record Key
c2795dd6-b2ca-4dd8-ba70-f8c76c9d9690
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302733200106
Quantity per Package
100
Contains DI Package
00302733200109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |