Duns Number:058614483
Device Description: Curved, Small Jaw, Open Sealer/Divider
Catalog Number
-
Brand Name
LigaSure
Version/Model Number
LF1212A
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
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
4d03ee84-4332-4006-8f0b-45d0bd372f71
Public Version Date
April 06, 2022
Public Version Number
3
DI Record Publish Date
May 09, 2018
Package DI Number
20884521744186
Quantity per Package
6
Contains DI Package
10884521744189
Package Discontinue Date
-
Package Status
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 |