Duns Number:080935429
Device Description: Female Urinary Specimen Catheter Kit,Prepping Components
Catalog Number
3411
Brand Name
Dover
Version/Model Number
3411
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"
-
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
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
bd93a852-5043-462d-b111-e8934ffaf8de
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884521004433
Quantity per Package
100
Contains DI Package
10884521004436
Package Discontinue Date
-
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 |