Duns Number:080935429
Device Description: Silicone Coated Latex Foley Catheter,30 mL, 2-Way, Hemostatic
Catalog Number
3614
Brand Name
Dover
Version/Model Number
3614
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
0c32375a-ca69-4dbd-866e-f32eabb3cc34
Public Version Date
December 04, 2020
Public Version Number
13
DI Record Publish Date
September 24, 2016
Package DI Number
30884521016822
Quantity per Package
10
Contains DI Package
10884521016828
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 |