Duns Number:016898496
Device Description: Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket Totalis Flexible Endo Kit with InLay Optima® Ureteral Stent, SkyLite™ Tipless Stone Basket and Solo™ Plus Hybrid Guidewire
Catalog Number
FEK24HW
Brand Name
Totalis™ Flexible Endo Kit
Version/Model Number
FEK24HW
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
10365f01-3d78-4ea0-89c2-61d58f12c2eb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 04, 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 |