Duns Number:627879687
Device Description: The ArC SMART Argon Probe 2.3, 330 is for exclusive use with the gi4000 Electrosurgical U The ArC SMART Argon Probe 2.3, 330 is for exclusive use with the gi4000 Electrosurgical Unit.
Catalog Number
G1140002
Brand Name
ARC SMART
Version/Model Number
ARC SMART Probe
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"
Yes
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
K130983,K130983
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
dd735c2d-0f75-49f5-a4ae-9419c47ef91c
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
10724995209091
Quantity per Package
10
Contains DI Package
00724995209094
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 |