Duns Number:009900424
Device Description: Dryz Blu Syringe Gingival Retraction Paste Value Pack (Pkg. of 25 Syringes)
Catalog Number
S191
Brand Name
Dryz™
Version/Model Number
S191
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"
-
For Single-Use
-
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
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
3cd48e5e-4391-4e2e-8ecc-e68185437f18
Public Version Date
September 20, 2019
Public Version Number
2
DI Record Publish Date
September 21, 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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |
| U | Unclassified | 19 |