Duns Number:534155213
Device Description: The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.
Catalog Number
UC0005
Brand Name
Urinary Catheter
Version/Model Number
Urinary Catheter, 12 Fr
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"
-
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
K211032,K211032
Product Code
EZC
Product Code Name
Catheter, Coude
Public Device Record Key
3f44168c-0882-4cda-92a0-0197c5934d5b
Public Version Date
June 09, 2022
Public Version Number
1
DI Record Publish Date
June 01, 2022
Package DI Number
20854913006116
Quantity per Package
10
Contains DI Package
10854913006119
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |