Duns Number:006261481
Device Description: STENT ONYXNG40012UX ONYX 4.00X12RX
Catalog Number
-
Brand Name
Onyx Frontier™
Version/Model Number
ONYXNG40012UX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P160043
Product Code
NIQ
Product Code Name
Coronary drug-eluting stent
Public Device Record Key
dfcba36e-eb5c-4179-a0ba-7696ac30e374
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 11, 2022
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |