Duns Number:016898496
Device Description: SureStep® Foley Tray System Bard Silicone Foley Catheter Tray with StatLock & 2000 ml Dra SureStep® Foley Tray System Bard Silicone Foley Catheter Tray with StatLock & 2000 ml Drainage Bag
Catalog Number
A897514
Brand Name
SureStep™ Foley Tray System Bard® All Silicone Foley Catheter Tray
Version/Model Number
A897514
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"
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
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
3e6dfe96-a803-40de-b511-7eade9add822
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
December 08, 2015
Package DI Number
10801741104517
Quantity per Package
10
Contains DI Package
00801741104510
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 |