Duns Number:627879687
Device Description: The ArConnect argon probe connector allows the delivery of monopolar high frequency electr The ArConnect argon probe connector allows the delivery of monopolar high frequency electrosurgical energy and argon gas to a single use argon coagulation probe (not included) and is for the exclusive use with the gi4000 Electrosurgical Unit.
Catalog Number
G1120020
Brand Name
ArConnect
Version/Model Number
G1120020
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
K192265,K192265
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
ed68d0ae-bf5b-478b-be33-53aa02777b33
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
10724995180284
Quantity per Package
10
Contains DI Package
00724995180287
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |