Duns Number:188684609
Device Description: SALINETRODE FLEX FLEXIBLE ELECTRODE
Catalog Number
-
Brand Name
Salinetrodflex Bipolar RF Electrode
Version/Model Number
4B 73 S
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"
-
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
FAS
Product Code Name
Electrode, Electrosurgical, Active, Urological
Public Device Record Key
b9771e05-1835-4532-b21d-16cf4e609d44
Public Version Date
April 23, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10851545007415
Quantity per Package
5
Contains DI Package
00851545007418
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 79 |