Duns Number:687793617
Device Description: The MISO bracket is indicated for orthodontic movement of natural teeth
Catalog Number
MBS181-553 W/Hook
Brand Name
MISO
Version/Model Number
MBS181-553
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)
-
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
8f1a35c7-7576-490f-9823-08db3b743d4d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 11, 2017
Package DI Number
08800022212922
Quantity per Package
5
Contains DI Package
08800022201506
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |