Duns Number:071595540
Device Description: CONMED Goldline Foot Controlled with Blade Electrode, Safety Holster and 10 FT. (3m) Cable CONMED Goldline Foot Controlled with Blade Electrode, Safety Holster and 10 FT. (3m) Cable Electrosurigal Handpiece
Catalog Number
138658A
Brand Name
CONMED Goldline
Version/Model Number
138658A
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
34c4b5c6-2cdf-4044-986a-b88e2592e6e3
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |