Duns Number:320744915
Device Description: Situation impression material - alginate substitute, medium-bodied consistency. Situations Situation impression material - alginate substitute, medium-bodied consistency. Situations that last. Content: 1 cartridge @ 380 ml paste, accessories.
Catalog Number
999693
Brand Name
StatusBlue MixStar
Version/Model Number
999693
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K013237,K013237,K013237
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
619d963b-19e4-45cf-a3af-f5aa5db8077f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
EDMG9996938
Quantity per Package
6
Contains DI Package
EDMG9996931
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |