Duns Number:527812392
Device Description: Disposable Rocker Switch Pencil ,Non-Coated Electrode Blade .White color of pencil with Disposable Rocker Switch Pencil ,Non-Coated Electrode Blade .White color of pencil with 3m color blue Cable ,3 prong plug .Standard hex over mold blade Non-Coated.
Catalog Number
-
Brand Name
Olympus
Version/Model Number
WA98211R
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
07e1d01c-3228-4519-ac98-6d358e15b40b
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
October 31, 2017
Package DI Number
36939029815041
Quantity per Package
100
Contains DI Package
26939029815044
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 165 |