Duns Number:607903382
Device Description: Cutting and coagulating Ball Tip Electrode. Nylon insulation. Fits most popular electrosur Cutting and coagulating Ball Tip Electrode. Nylon insulation. Fits most popular electrosurgical handles.
Catalog Number
SE79B
Brand Name
Greenwald Surgical Company, Inc.
Version/Model Number
25100-00
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
-
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
d2fd3740-dbe7-49fd-a5ec-138de812b42d
Public Version Date
July 18, 2018
Public Version Number
3
DI Record Publish Date
February 19, 2018
Package DI Number
10801334014056
Quantity per Package
5
Contains DI Package
10801334000875
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 186 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 220 |