Duns Number:071595540
Device Description: GOLDVAC PUSH BUTTON, 15', ELECTROSURGICAL SMOKE EVACUATION HANDPIECE
Catalog Number
60-7570-005
Brand Name
GOLDVAC
Version/Model Number
60-7570-005
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
6e9bb846-ca48-49ee-a700-02a305122b4d
Public Version Date
December 28, 2020
Public Version Number
1
DI Record Publish Date
December 19, 2020
Package DI Number
20653405061196
Quantity per Package
10
Contains DI Package
10653405061199
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 |