Duns Number:044606982
Device Description: LIGACLIP MCA Multiple Clip Appliers, 30 Medium Clips
Catalog Number
MCM30
Brand Name
LIGACLIP
Version/Model Number
MCM30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
GDO
Product Code Name
Applier, surgical, clip
Public Device Record Key
ad5907e0-f4ed-4d7c-9e3d-13c46e2f34bb
Public Version Date
October 28, 2019
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036002486
Quantity per Package
24
Contains DI Package
10705036002482
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 |