Duns Number:688360116
Device Description: Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be Sterile Single-use Surgical Instrument used with electrosurgical generator intended to be used during laparoscopic procedure for manipulation of tissue to cauterize, grasp and dissect tissue.
Catalog Number
-
Brand Name
Artisential Bipolar Fenestrated Forceps
Version/Model Number
ABF01-L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2020
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
K190909
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
5e8d20d4-fe5b-494a-aadd-dbe1d4d5a9ce
Public Version Date
September 23, 2020
Public Version Number
2
DI Record Publish Date
March 13, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |