Duns Number:006261481
Device Description: STENT RONYX40015W RESOLUTE ONYX 4.00X15
Catalog Number
-
Brand Name
Resolute Onyx™
Version/Model Number
RONYX40015W
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,P160043,P160043,P160043,P160043,P160043
Product Code
NIQ
Product Code Name
Coronary drug-eluting stent
Public Device Record Key
1859c892-4a6e-40f7-b539-01e3fff2d391
Public Version Date
June 11, 2021
Public Version Number
7
DI Record Publish Date
May 11, 2017
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 |