Duns Number:831465641
Device Description: AGILITY® CERAMIC MBT .018 LR3 HK -6°T +3°A BRACKETS
Catalog Number
-
Brand Name
G&H ORTHODONTICS®
Version/Model Number
126-L3-8RK-V
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
K132368,K132368
Product Code
NJM
Product Code Name
Bracket, Ceramic, Orthodontic
Public Device Record Key
d25a794b-3278-48c6-8a9b-e157b772b509
Public Version Date
December 19, 2019
Public Version Number
1
DI Record Publish Date
December 11, 2019
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |