Catalog Number
ECK085
Brand Name
RUSCH
Version/Model Number
IPN053605
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"
Yes
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
K000070,K000070,K000070
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
598f64a5-a9cd-43d4-b9ec-efe27b552ef2
Public Version Date
December 04, 2020
Public Version Number
9
DI Record Publish Date
September 16, 2016
Package DI Number
44026704325861
Quantity per Package
2
Contains DI Package
24026704325867
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 |