Duns Number:305524696
Device Description: Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheteri Ready to use curved tip male catheter. Sterile urinary catheter for intermittent catheterization
Catalog Number
20014
Brand Name
SpeediCath Flex Coude Pro
Version/Model Number
20014
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
K190620,K190620,K190620
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
a16bbf01-73d7-499f-ab75-a871b5bf4746
Public Version Date
July 22, 2019
Public Version Number
1
DI Record Publish Date
July 12, 2019
Package DI Number
05708932125383
Quantity per Package
3
Contains DI Package
05708932125376
Package Discontinue Date
-
Package Status
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 |