Duns Number:016898496
Device Description: Sure Step® Foley Tray SystemBardex® Lubricath® Temperature Sensing Foley Catheter Tray 350 Sure Step® Foley Tray SystemBardex® Lubricath® Temperature Sensing Foley Catheter Tray 350 ml Urine Meter
Catalog Number
A909116M
Brand Name
Sure Step™ Foley Tray System Bardex® Lubricath® Foley Catheter Tray
Version/Model Number
A909116M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2022
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
EZC
Product Code Name
CATHETER, COUDE
Public Device Record Key
cecfdd1f-1fce-4e39-afb1-7ea117460543
Public Version Date
May 18, 2022
Public Version Number
4
DI Record Publish Date
December 08, 2015
Package DI Number
10801741108805
Quantity per Package
10
Contains DI Package
00801741108808
Package Discontinue Date
September 30, 2021
Package Status
Not 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 |