Duns Number:094651270
Device Description: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 5 French
Catalog Number
4195007
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
de1f748e-24a8-4d81-bc40-61b6de3aa291
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H67141950071
Quantity per Package
10
Contains DI Package
H67141950070
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 |