Duns Number:016898496
Device Description: Totalis™ Rigid Endo Kit with InLay® Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nit Totalis™ Rigid Endo Kit with InLay® Ureteral Stent, EcoFlex™ Stone Basket and NiCore® Nitinol Guidewire
Catalog Number
REK24N
Brand Name
Totalis™ Rigid Endo Kit
Version/Model Number
REK24N
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
bac42079-601a-4ed6-9115-d461221ec8eb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
May 14, 2015
Package DI Number
10801741097574
Quantity per Package
5
Contains DI Package
00801741097577
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| 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 |