Duns Number:113170088
Device Description: Mixing Wells are intended for use as a receptacle for dispensed resins and sealants and fo Mixing Wells are intended for use as a receptacle for dispensed resins and sealants and for mixing.
Catalog Number
1MXW
Brand Name
MIXING WELL
Version/Model Number
1MXW
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECP
Product Code Name
Instrument, Ligature Tucking, Orthodontic
Public Device Record Key
a2ee7b8a-0848-4c0f-a28e-2adc19ded180
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |