Duns Number:064783913
Device Description: "Mighty Mixer Bowl 36pk Assorted, Disposable, eliminating cleanup time, Fits securely into "Mighty Mixer Bowl 36pk Assorted, Disposable, eliminating cleanup time, Fits securely into mixing bowl without slippage, Free-standing for use with or without mixing bowl, Capable for use with electric Alginate mixers9 x Teal9 x Neon Blue9 x Neon Green9 x Neon Purple"
Catalog Number
-
Brand Name
Mighty Mixer Bowl
Version/Model Number
50Z505-ASTD
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
d84fb4e7-1fec-44ec-8d30-ff4a95581fca
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
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 | 399 |