Duns Number:078444642
Device Description: Enthus VPS Impression Material, Putty, Fast Set, Spearmint Flavor, 1 x 300ml Base, 1 x 300 Enthus VPS Impression Material, Putty, Fast Set, Spearmint Flavor, 1 x 300ml Base, 1 x 300ml Catalyst, 2 Spoons
Catalog Number
38-00002
Brand Name
Enthus
Version/Model Number
38-00002
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
11d88014-265a-4a0f-ad32-1dcf1531ee42
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2016
Package DI Number
10353045001783
Quantity per Package
6
Contains DI Package
00353045001786
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |