Duns Number:030479000
Device Description: M&S DENTAL CORE MATERIAL T-MIXER BROWN 1:1 BLUNT END 20 PER BAG
Catalog Number
VPS8150T
Brand Name
IMPRESS-RITE T-MIXING TIPS
Version/Model Number
VPS8150T
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EID
Product Code Name
Syringe, Restorative And Impression Material
Public Device Record Key
0cf182a7-f911-4180-a082-120c8e267ea4
Public Version Date
December 22, 2020
Public Version Number
1
DI Record Publish Date
December 14, 2020
Package DI Number
00818524020684
Quantity per Package
20
Contains DI Package
00818524020660
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |