Duns Number:016898496
Device Description: INLAY OPTIMA URETERAL STENT W/HYDROGLIDE GUIDEWIRE
Catalog Number
787728
Brand Name
Bard® InLay Optima® Ureteral Stent with HydroGlide™ Guidewire
Version/Model Number
787728
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
FAD
Product Code Name
STENT, URETERAL
Public Device Record Key
ab965598-6a1c-40d4-9d50-8df9d293c921
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 22, 2015
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 | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |