Duns Number:071595540
Device Description: Laparoscopic Electrode
Catalog Number
60-5160-002
Brand Name
NA
Version/Model Number
60-5160-002
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
K904240,K904240,K904240
Product Code
HFG
Product Code Name
COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)
Public Device Record Key
5df5d021-eb81-45ca-af65-d4d7e69f0828
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405009686
Quantity per Package
5
Contains DI Package
30653405009683
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |