Duns Number:044668515
Device Description: DB BKT SS UL CUSP 018 T+7 A+5 R=0 W/HK DIST NARROW STD 092 PAD
Catalog Number
092-511HDUL
Brand Name
Stainless Steel Brackets
Version/Model Number
092-511HDUL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 07, 2022
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
EJF
Product Code Name
BRACKET, METAL, ORTHODONTIC
Public Device Record Key
8501bb2c-2579-43a0-b56b-f8c5f3d669e6
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
August 26, 2021
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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |