Duns Number:002348191
Device Description: 8FR Pediatric
Catalog Number
EC080
Brand Name
RUSCH
Version/Model Number
IPN054328
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,K000070
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
0d19cc0c-c13b-4f4b-90b0-0348858396f4
Public Version Date
January 18, 2021
Public Version Number
6
DI Record Publish Date
August 13, 2019
Package DI Number
24026704662825
Quantity per Package
50
Contains DI Package
14026704662828
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 |