Duns Number:264592326
Device Description: (Fr26)
Catalog Number
MV1
Brand Name
Front load bipolar electrode
Version/Model Number
Bipolar cutting loop / THIN OLYMPUS compatible
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2022
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)
-
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
54d409f7-fc47-462f-a69e-47bc6f69cebc
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
October 09, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |