Duns Number:013369913
Device Description: ViscoStat Clear Dento-Infusor Indispense Kit
Catalog Number
6407
Brand Name
ViscoStat Clear
Version/Model Number
6407
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
54a36fcc-762f-4c7f-b35c-1a4b3e6dee88
Public Version Date
May 29, 2018
Public Version Number
1
DI Record Publish Date
April 28, 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 | 450 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 631 |
| U | Unclassified | 18 |