Duns Number:012676012
Device Description: Vaccu-Sil Light Body Impression Material is pre-loaded in the Mojo disposable single use s Vaccu-Sil Light Body Impression Material is pre-loaded in the Mojo disposable single use syringe.Fast Set, Single Use, 50/Box
Catalog Number
-
Brand Name
Vaccu-Sil Mojo Complete Light Body Syringe
Version/Model Number
Fast Set
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
3ff46670-e494-4703-ae38-3b565a4053ad
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 10, 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 | 5 |