Duns Number:071595540
Device Description: CONMED GOLDLINE FOOT CONTROLLED WITH NEEDLE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABL CONMED GOLDLINE FOOT CONTROLLED WITH NEEDLE ELECTRODE SAFETY HOLSTER AND 10 FOOT (3M) CABLE, ELECTROSURGICAL HANDPIECE
Catalog Number
138652A
Brand Name
CONMED
Version/Model Number
138652A
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
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
143bcb08-0266-453e-a190-10ff2328f014
Public Version Date
February 07, 2019
Public Version Number
2
DI Record Publish Date
July 02, 2018
Package DI Number
20653405056680
Quantity per Package
40
Contains DI Package
10653405056683
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 |