Duns Number:317654283
Device Description: E-Cath Plus acc. Tsui SonoPlex Stim cannula 21G x 94mm indwelling E-Cath Plus acc. Tsui SonoPlex Stim cannula 21G x 94mm indwelling catheter 18G x 75mm
Catalog Number
211185-41E
Brand Name
E-Cath Plus acc. Tsui
Version/Model Number
211185-41E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
6a5c2d24-df40-48f6-bdc9-263ca8549dff
Public Version Date
December 31, 2019
Public Version Number
6
DI Record Publish Date
October 14, 2016
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 |