Duns Number:071595540
Device Description: CONMED ELECTROSURGICAL ACCESSORY, BALL ELECTRODE, 3MM, EXTENDED SHAFT
Catalog Number
60-5181-102
Brand Name
CONMED
Version/Model Number
60-5181-102
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
K913213,K913213,K913213
Product Code
HGI
Product Code Name
ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
61a98780-a0c8-4a02-8e74-23e9b96293b7
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405010255
Quantity per Package
5
Contains DI Package
30653405010252
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 |