Duns Number:033505389
Device Description: ADVANCE VPS MINT F.S. HVY. BODY PK/4 50ML CART.
Catalog Number
33319
Brand Name
Advance Dental Products
Version/Model Number
33319
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
674f9d36-a101-4108-bf1f-055764f3b495
Public Version Date
November 12, 2020
Public Version Number
1
DI Record Publish Date
November 04, 2020
Package DI Number
20850002458910
Quantity per Package
10
Contains DI Package
10850002458913
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |