Duns Number:627879687
Device Description: The GoCart mobile cart is used to store your gi4000 electrosurgery unit for easy transport The GoCart mobile cart is used to store your gi4000 electrosurgery unit for easy transport and and includes two storage baskets with easy roll and lock wheels.
Catalog Number
G1112004
Brand Name
NA
Version/Model Number
G1112004
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
K113265,K172805,K192265
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
3f0223b8-d03b-46c0-bcec-85f012de9156
Public Version Date
February 15, 2022
Public Version Number
2
DI Record Publish Date
April 23, 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |