Duns Number:305524696
Device Description: Ready to use male catheter. Sterile urinary catheter for intermittent catheterization.
Catalog Number
28920
Brand Name
SpeediCath Flex Coude
Version/Model Number
28920
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2020
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
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
390b2892-a1e7-417b-9f8d-63b5425aabfd
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
November 04, 2016
Package DI Number
05708932643672
Quantity per Package
3
Contains DI Package
05708932017220
Package Discontinue Date
June 18, 2020
Package Status
Not in Commercial Distribution
Package Type
shipper 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 |