Duns Number:025460908
Device Description: CATHETER, URETHRAL, COUDE, VINYL, 16
Catalog Number
URO3PVC1616C
Brand Name
Medline
Version/Model Number
URO3PVC1616C
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
-
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
84b194b6-562c-4d32-a513-1ee8d6fdc073
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 14, 2016
Package DI Number
40884389196725
Quantity per Package
30
Contains DI Package
10884389196724
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |