Duns Number:305524696
Device Description: Self-Cath®. Urinary Catheter. Straight Tip Male. Catheter Gauge 18 FR/CH, Diameter 6.0 mm.
Catalog Number
50455 / 418
Brand Name
Self-Cath
Version/Model Number
50455 / 418
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
K100878,K100878,K100878
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
52c56ecf-4ea2-4738-a30a-1f4854940fcd
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 08, 2021
Package DI Number
05708932735353
Quantity per Package
30
Contains DI Package
05708932735346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |