Duns Number:154614119
Device Description: SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI UPPER 5-5 WITH HOOKS ON 3 .022
Catalog Number
-
Brand Name
Symetri Clear
Version/Model Number
746-2205
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
6a5ecbb4-c9ba-4a3c-91f9-298ff8e1bd62
Public Version Date
April 02, 2018
Public Version Number
1
DI Record Publish Date
March 01, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |