Duns Number:154614119
Device Description: SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UP/LO 5-5 WITH HOOKS 3-4-5 .018
Catalog Number
-
Brand Name
Symetri Clear
Version/Model Number
746-2101
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
22ea1f9c-8939-4127-a533-89b6d31640fc
Public Version Date
April 10, 2019
Public Version Number
1
DI Record Publish Date
April 02, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |