Duns Number:809784593
Device Description: Female Catheter
Catalog Number
505596
Brand Name
RUSCH Catheter
Version/Model Number
505596
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 18, 2019
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
bcda328d-b5e5-496b-afec-172db21ab722
Public Version Date
January 14, 2020
Public Version Number
3
DI Record Publish Date
February 10, 2017
Package DI Number
50768455145930
Quantity per Package
100
Contains DI Package
30768455145936
Package Discontinue Date
December 18, 2019
Package Status
Not 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |