Duns Number:016898496
Device Description: SureStep® Foley Tray SystemBardex® Lubricath® Foley Catheter Tray & 350 ml Urine Meter
Catalog Number
A304914
Brand Name
SureStep™ Foley Tray System
Version/Model Number
A304914
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)
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
5d86776c-3f56-4a95-968f-9f3caf81d752
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
December 08, 2015
Package DI Number
10801741104357
Quantity per Package
10
Contains DI Package
00801741104350
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 |