Duns Number:080935429
Device Description: 100% Silicone Foley Catheter,30 mL, 2-Way, Hemostatic
Catalog Number
8887630260
Brand Name
Dover
Version/Model Number
8887630260
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
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
8e73a741-34d7-40bf-b363-7a5ba2471927
Public Version Date
August 26, 2022
Public Version Number
14
DI Record Publish Date
October 20, 2016
Package DI Number
30884521015887
Quantity per Package
60
Contains DI Package
20884521015880
Package Discontinue Date
July 01, 2023
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |