Duns Number:907156371
Device Description: Bracket Prescription M.B.T. - PolySafira .022" - 31,32,41,42
Catalog Number
10.33.008
Brand Name
Morelli
Version/Model Number
10.33.008
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
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
NJM
Product Code Name
Bracket, ceramic, orthodontic
Public Device Record Key
97198e4c-3230-4ab4-aede-a81d20133c8a
Public Version Date
September 20, 2022
Public Version Number
1
DI Record Publish Date
September 12, 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 | 1414 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |