Duns Number:809784593
Device Description: Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packe Sterile Intermittent Urinary Catheter with Funnel End, Hydrophilic Coated with water packet and gripper, Coudé Tip
Catalog Number
-
Brand Name
CURE CATHETER
Version/Model Number
HM12C
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
K132500,K132500,K132500
Product Code
EZD
Product Code Name
Catheter, Straight
Public Device Record Key
4e9bea54-3e26-4d9d-84de-6cdec8692b3d
Public Version Date
October 31, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10815947020335
Quantity per Package
30
Contains DI Package
00815947020338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |