Duns Number:080935429
Device Description: 100% Silicone Foley Catheter,5 mL, 3-Way
Catalog Number
8887664161
Brand Name
Dover
Version/Model Number
8887664161
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
bc43c437-0ac9-47bc-b04f-cfb4a4841ae9
Public Version Date
January 28, 2022
Public Version Number
14
DI Record Publish Date
September 24, 2016
Package DI Number
30884521019960
Quantity per Package
60
Contains DI Package
10884521019966
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 |