Duns Number:689698269
Device Description: Impression Material, Polyvinyl Siloxane ; Putty consistency ; Base 50ml x 1 jar, Catalyst Impression Material, Polyvinyl Siloxane ; Putty consistency ; Base 50ml x 1 jar, Catalyst 50ml x 1 jar
Catalog Number
-
Brand Name
Vonflex Putty
Version/Model Number
VF305-PS00
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
aac6b6d3-4d42-436c-8cd0-924052b131bf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 21, 2017
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 201 |