Duns Number:078444642
Device Description: Enthus VPS Impression Material, Heavy Body, Fast Set, Spearmint Flavor, 4 x 50ml Cartridge Enthus VPS Impression Material, Heavy Body, Fast Set, Spearmint Flavor, 4 x 50ml Cartridges
Catalog Number
38-00009
Brand Name
Enthus
Version/Model Number
38-00009
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
K041028,K041028,K041028
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
5d877e08-0b22-471b-88fa-7a418802540b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
10353045001851
Quantity per Package
12
Contains DI Package
00353045001854
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 |