Duns Number:044606982
Device Description: Ligaclip Clip Applier Large, Right Angle 26.7cm
Catalog Number
LX430
Brand Name
LIGACLIP
Version/Model Number
LX430
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
-
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
GDO
Product Code Name
Applier, surgical, clip
Public Device Record Key
cad01498-e6c2-4aaa-a095-59785bbb3d76
Public Version Date
February 07, 2022
Public Version Number
1
DI Record Publish Date
January 28, 2022
Package DI Number
30705036026994
Quantity per Package
25
Contains DI Package
20705036026997
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |