Duns Number:005527098
Device Description: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 10 Fr 16 in
Catalog Number
-
Brand Name
Advance Plus
Version/Model Number
96104IC
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
-
Product Code
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
cfd67534-9e15-4b47-8d52-df9cc0a3bbd2
Public Version Date
December 06, 2021
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
10610075102102
Quantity per Package
4
Contains DI Package
00610075102105
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |