Duns Number:228480810
Device Description: S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr. 10cc, 42 S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 14Fr. 10cc, 42cm
Catalog Number
-
Brand Name
S-Cath™
Version/Model Number
5754
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
K132890,K132890
Product Code
KOB
Product Code Name
CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Public Device Record Key
9d75d010-d467-48ba-b055-8dfb83e1552d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2015
Package DI Number
15055140702262
Quantity per Package
5
Contains DI Package
05055140702265
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |