Duns Number:020198912
Device Description: LigaSure Maryland Jaw, Without Nano-coating, 44cm, Open/Lap Sealer/Divider
Catalog Number
LF1944
Brand Name
N/A
Version/Model Number
LF1944
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
K180499,K180499
Product Code
NUJ
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Public Device Record Key
cafe525d-acb9-4b1e-b62e-f3501c8b3be8
Public Version Date
March 31, 2020
Public Version Number
3
DI Record Publish Date
March 04, 2020
Package DI Number
57613327504908
Quantity per Package
6
Contains DI Package
07613327504903
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 | 304 |
2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
U | Unclassified | 12 |