Duns Number:071595540
Device Description: CONMED REUSABLE WITH ROCKER SWITCH AND BLADE ELECTRODE ELECTROSURGICAL HANDPIECE
Catalog Number
130316-15NS
Brand Name
CONMED
Version/Model Number
130316-15NS
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
9c4bab06-46c1-4103-a6e2-28560634e829
Public Version Date
December 08, 2020
Public Version Number
1
DI Record Publish Date
November 30, 2020
Package DI Number
20653405033070
Quantity per Package
10
Contains DI Package
10653405033073
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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 |