Duns Number:317654283
Device Description: E-Cath acc. Tsui SonoPlex Stim cannula 21G x 101mm indwelling E-Cath acc. Tsui SonoPlex Stim cannula 21G x 101mm indwelling catheter 18G x 83mm
Catalog Number
241285-40E
Brand Name
E-Cath acc. Tsui
Version/Model Number
241285-40E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
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
K152952,K152952
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
1572b1e2-c716-4a14-91e8-5732d5aca52d
Public Version Date
March 16, 2021
Public Version Number
3
DI Record Publish Date
December 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |