Duns Number:044668515
Device Description: DB BKT MINI MS LOWER 2ND BIC 018 T-22 A=0 R=0 BEV OFFSET PAD GP
Catalog Number
390-8021AU
Brand Name
Mini Master Series
Version/Model Number
390-8021AU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 19, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJF
Product Code Name
BRACKET, METAL, ORTHODONTIC
Public Device Record Key
236d0829-afcc-4088-8d67-0a2120b74a83
Public Version Date
January 20, 2022
Public Version Number
2
DI Record Publish Date
October 09, 2020
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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |