Catalog Number
331105
Brand Name
RUSCH
Version/Model Number
IPN038981
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K850335,K850335,K850335,K850335
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
2b57f65d-7a2c-4669-bbea-2f000c9d8221
Public Version Date
January 18, 2021
Public Version Number
7
DI Record Publish Date
June 07, 2019
Package DI Number
34026704663249
Quantity per Package
10
Contains DI Package
24026704663242
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |