Duns Number:016898496
Device Description: SureStep® Foley Tray System (Add-A-Foley Catheter Tray 350 ml Urine Meter)
Catalog Number
A904100
Brand Name
SureStep™ Foley Tray System
Version/Model Number
A904100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 17, 2022
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"
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
KNX
Product Code Name
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Public Device Record Key
b4a0d11d-fc6c-4209-a6b7-f21f03610bde
Public Version Date
May 18, 2022
Public Version Number
5
DI Record Publish Date
December 08, 2015
Package DI Number
10801741104722
Quantity per Package
10
Contains DI Package
00801741104725
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 |