Duns Number:809784593
Device Description: Closed System Single Urinary Catheterization System, Straight Tip
Catalog Number
-
Brand Name
Cure Dextra
Version/Model Number
DEX18
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
KOD
Product Code Name
Catheter, Urological
Public Device Record Key
6a3baa2c-d75c-4464-a746-62a0777b3662
Public Version Date
February 02, 2022
Public Version Number
3
DI Record Publish Date
August 28, 2020
Package DI Number
10815947021271
Quantity per Package
90
Contains DI Package
00815947021274
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 |