Duns Number:184763290
Catalog Number
RCX22-10-038
Brand Name
ReSolve ConvertX®
Version/Model Number
00884450453094
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FAD
Product Code Name
Stent, ureteral
Public Device Record Key
7974479e-cd22-416f-babf-7ec076b868b8
Public Version Date
October 11, 2021
Public Version Number
2
DI Record Publish Date
February 25, 2020
Package DI Number
10884450453091
Quantity per Package
1
Contains DI Package
00884450453094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |