Duns Number:627879687
Device Description: The gi4000 Electrosurgical Unit -Loaner is designed specifically for flexible endoscopy an The gi4000 Electrosurgical Unit -Loaner is designed specifically for flexible endoscopy and has Argon, Monopolar, Bipolar and Lavage functions all built into the one easy-to-use, compact unit.
Catalog Number
G1200000
Brand Name
NA
Version/Model Number
gi4000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192265,K220395
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
9c53a0ea-051f-4679-999c-123588532fbc
Public Version Date
April 29, 2022
Public Version Number
2
DI Record Publish Date
February 18, 2022
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 |