Duns Number:020956330
Device Description: UL/LR CONLIN LIGHT WIRE SS BRACKETS CENT/LAT (5)
Catalog Number
405-902
Brand Name
CONLIN LIGHT WIRE SS BRACKETS
Version/Model Number
UL/LR CONLIN CENT/LAT
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
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
2bca8bef-85bd-4cb8-b9a2-6ff3db52a2af
Public Version Date
June 24, 2022
Public Version Number
1
DI Record Publish Date
June 16, 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 | 1814 |
2 | A medical device with a moderate to high risk that requires special controls. | 130 |