Duns Number:527812392
Device Description: Open-surgery electrosurgical electrode, monopolar, single-use .Electrode, Blade, 6", Non-C Open-surgery electrosurgical electrode, monopolar, single-use .Electrode, Blade, 6", Non-Coated.
Catalog Number
-
Brand Name
Olympus
Version/Model Number
WA98551E
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
68b421f3-3f74-4546-a7c5-bc2654e6d8b1
Public Version Date
February 07, 2019
Public Version Number
2
DI Record Publish Date
March 05, 2018
Package DI Number
36939029816772
Quantity per Package
10
Contains DI Package
26939029816775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 165 |