Duns Number:527812392
Device Description: Disposable foot control Electrosurgical Pencil with 3m color blue Cable,Non-Coated Electr Disposable foot control Electrosurgical Pencil with 3m color blue Cable,Non-Coated Electrode Blade.
Catalog Number
-
Brand Name
Olympus
Version/Model Number
WA98211F
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
86bfdbdb-0b70-4e42-a6c7-811970268d9d
Public Version Date
February 07, 2019
Public Version Number
2
DI Record Publish Date
March 21, 2018
Package DI Number
36939029817281
Quantity per Package
2
Contains DI Package
26939029817284
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 |