Duns Number:058614483
Device Description: Tissue Fusion Open Instrument
Catalog Number
LF4200
Brand Name
LigaSure Impact
Version/Model Number
LF4200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 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
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
c4b6871e-5b49-4927-b6ac-bf8de9d6b4f6
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20884521103358
Quantity per Package
6
Contains DI Package
10884521103351
Package Discontinue Date
April 28, 2020
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |