Duns Number:044606982
Device Description: Ligaclip Endoscopic Clip Applier Medium Large 35.6 cm
Catalog Number
EL314
Brand Name
LIGACLIP
Version/Model Number
EL314
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
HBT
Product Code Name
APPLIER, HEMOSTATIC CLIP
Public Device Record Key
5a0086d9-181c-46eb-acc0-7c9f4c28f83a
Public Version Date
August 21, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036003858
Quantity per Package
12
Contains DI Package
20705036003851
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 |