Duns Number:002348191
Device Description: 2 WAY 10ml PVC SUPRAPUBIC PUNCTURE INSTRUMENT, STERILE PACK
Catalog Number
650704160
Brand Name
RUSCH
Version/Model Number
IPN050002
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)
Yes
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
K952187,K952187,K952187
Product Code
KOB
Product Code Name
CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Public Device Record Key
5cc8bda2-d730-41df-bbf6-bc6de1023f00
Public Version Date
December 04, 2020
Public Version Number
9
DI Record Publish Date
October 16, 2015
Package DI Number
24026704437225
Quantity per Package
5
Contains DI Package
04026704437221
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 |