Duns Number:016898496
Device Description: SureStep™ Foley Tray System Bard® All-Silicone Temperature Sensing Foley Catheter Tray 350 SureStep™ Foley Tray System Bard® All-Silicone Temperature Sensing Foley Catheter Tray 350 ml Urine Meter
Catalog Number
A119108
Brand Name
SureStep™ Foley Tray System with Bard® All-Silicone Temp Sensing Catheter
Version/Model Number
A119108
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
765bf388-4e8b-474d-91f1-31c2907c0569
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
March 19, 2016
Package DI Number
10801741100571
Quantity per Package
10
Contains DI Package
00801741100574
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 |