Duns Number:002348191
Device Description: Catheter plug, sterile
Catalog Number
548500-000000
Brand Name
RUSCH
Version/Model Number
IPN052696
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
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
7537df7f-10bc-44e9-a456-45cafe6fe12e
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
24026704067569
Quantity per Package
50
Contains DI Package
04026704067565
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 |