Duns Number:002348191
Device Description: 2 WAY 10ml PVC SUPRAPUBIC PUNCTURE INSTRUMENT, STERILE PACK
Catalog Number
650704100
Brand Name
RUSCH
Version/Model Number
IPN050000
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
e93755b3-c6ee-4ec5-8d68-70d8334a8d47
Public Version Date
December 04, 2020
Public Version Number
10
DI Record Publish Date
October 16, 2015
Package DI Number
44026704437205
Quantity per Package
10
Contains DI Package
24026704437201
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 |