Duns Number:080935429
Device Description: Silicone Elastomer Coated Latex Foley Catheter,5 mL, 3-Way
Catalog Number
8887688185
Brand Name
Dover
Version/Model Number
8887688185
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
-
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
f2e901d8-be05-4d61-bd5e-af670fc17852
Public Version Date
October 28, 2019
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884521017054
Quantity per Package
10
Contains DI Package
30884521017058
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |