Duns Number:809784593
Device Description: Closed System Complete Urinary Catheterization System, Straight Tip
Catalog Number
-
Brand Name
Cure Catheter® Closed System
Version/Model Number
CS8BZK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
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
FCM
Product Code Name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Public Device Record Key
479ceb31-9849-4b73-8a07-1de3fd1ce232
Public Version Date
February 02, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10815947020526
Quantity per Package
100
Contains DI Package
00815947020529
Package Discontinue Date
February 01, 2022
Package Status
Not 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 |