Duns Number:809784593
Device Description: Closed System Single Urinary Catheterization System, Straight Tip
Catalog Number
-
Brand Name
CURE DEXTRA
Version/Model Number
DEX16
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
KOD
Product Code Name
Catheter, Urological
Public Device Record Key
59f50726-cc27-4a3a-855a-5fd60fc184b2
Public Version Date
October 27, 2022
Public Version Number
3
DI Record Publish Date
August 28, 2020
Package DI Number
10815947021264
Quantity per Package
90
Contains DI Package
00815947021267
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 |