Duns Number:002348191
Device Description: Bladder catether, Tiemann, 2 eyes
Catalog Number
221800-000140
Brand Name
RUSCH
Version/Model Number
IPN050972
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
-
Product Code
EZC
Product Code Name
CATHETER, COUDE
Public Device Record Key
85f9dec1-3688-44ba-bc6a-6303d4917f25
Public Version Date
April 08, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
24026704031829
Quantity per Package
50
Contains DI Package
04026704031825
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |