Duns Number:044606982
Device Description: Ligaclip Clip Applier Medium 19cm
Catalog Number
LX207
Brand Name
LIGACLIP
Version/Model Number
LX207
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
dda8a7c0-562e-4b77-8c5e-3cf452076d16
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036012898
Quantity per Package
100
Contains DI Package
20705036012891
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 |