Duns Number:305524696
Device Description: Intermittent urinary drainage catheter. Ready to use. Nelaton
Catalog Number
27012
Brand Name
SpeediCath Soft
Version/Model Number
27012
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
K200142,K200142,K200142
Product Code
GBM
Product Code Name
CATHETER, URETHRAL
Public Device Record Key
4498bde5-639b-4532-bad7-1d1eece3a8f9
Public Version Date
November 04, 2020
Public Version Number
2
DI Record Publish Date
August 26, 2020
Package DI Number
05708932715652
Quantity per Package
10
Contains DI Package
05708932715645
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 |