Duns Number:658122465
Device Description: Monopolar scissors
Catalog Number
-
Brand Name
CONMED
Version/Model Number
1221
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2019
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"
Yes
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
58596ca6-d6a0-4e6b-a911-b09a393ab682
Public Version Date
February 17, 2020
Public Version Number
4
DI Record Publish Date
April 10, 2019
Package DI Number
20412786063324
Quantity per Package
10
Contains DI Package
10412786063327
Package Discontinue Date
October 31, 2019
Package Status
Not 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 67 |