Duns Number:809784593
Device Description: Closed System Complete Urinary Catheterization System, Straight Tip
Catalog Number
-
Brand Name
CURE CATHETER CLOSED SYSTEM
Version/Model Number
CS14
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
K080881,K080881
Product Code
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
539a2d44-34fb-435e-8652-d09d70939415
Public Version Date
October 26, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10815947020670
Quantity per Package
100
Contains DI Package
00815947020673
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |