Duns Number:199354556
Device Description: Mighty Mix; Hydrophilic Vinyl Polysiloxane Impression Material; 5:1 Cartridge System; Univ Mighty Mix; Hydrophilic Vinyl Polysiloxane Impression Material; 5:1 Cartridge System; Universal Body
Catalog Number
-
Brand Name
Correct Plus
Version/Model Number
Q34MA
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
65dbb36e-e326-47e7-b562-2cafc33d21d6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 01, 2016
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 | 98 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 595 |
| U | Unclassified | 5 |