Duns Number:062165188
Device Description: Maestro® .022 Kit U/L 6x6 MC HKS
Catalog Number
-
Brand Name
Maestro®
Version/Model Number
711-399MC-BT6Q
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
EJF
Product Code Name
BRACKET, METAL, ORTHODONTIC
Public Device Record Key
ad4d7b50-f288-4c83-b6cd-c720ebc7801c
Public Version Date
August 03, 2018
Public Version Number
1
DI Record Publish Date
July 03, 2018
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 | 8511 |
2 | A medical device with a moderate to high risk that requires special controls. | 1527 |