Duns Number:688360116
Device Description: Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during lapa Sterile Single-use Electrosurgical Instrument used for cutting and coagulation during laparoscopic procedure
Catalog Number
-
Brand Name
Artisential Monopolar Hook
Version/Model Number
AMHR01-F
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
K200501
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
6b818a14-8023-455e-b9ca-ee5bacf9926a
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 15, 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 |