Duns Number:186285342
Device Description: Vinyl Polysiloxane Putty, 2 putty jars (300ml Catalyst & 300ml Base) (600 ml total) & 2 sc Vinyl Polysiloxane Putty, 2 putty jars (300ml Catalyst & 300ml Base) (600 ml total) & 2 scoops
Catalog Number
-
Brand Name
MASTER-DENT
Version/Model Number
20-000
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
-
Product Code Name
-
Public Device Record Key
220c4eaf-a9eb-4df4-89a2-2f955b387076
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |