Duns Number:063167128
Device Description: Standard Edgewise TW Edge T 022/L1&2 UNIV MED
Catalog Number
36-2610-0053
Brand Name
Standard Edgewise
Version/Model Number
36-2610-0053
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
134f67fb-7ab3-481c-8bdf-54d2ca5bb912
Public Version Date
February 24, 2020
Public Version Number
1
DI Record Publish Date
February 14, 2020
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 | 1781 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |