Duns Number:094651270
Device Description: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 6.5 French
Catalog Number
4196507
Brand Name
URI-CATH
Version/Model Number
Silicone Catheter Set
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K941672,K941672
Product Code
GBM
Product Code Name
Catheter, Urethral
Public Device Record Key
23fba482-5782-471c-941f-cc07c3c4872f
Public Version Date
June 02, 2022
Public Version Number
1
DI Record Publish Date
May 25, 2022
Package DI Number
H67141965071
Quantity per Package
10
Contains DI Package
H67141965070
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |