Duns Number:044606982
Device Description: LIGACLIP EXTRA Ligating Clip Cartridges: 6 Titanium Clips/ Cartridge (Small)
Catalog Number
LT100
Brand Name
LIGACLIP
Version/Model Number
LT100
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
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
6b66f1a2-881f-4842-b007-95c4a5f348c8
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
August 24, 2015
Package DI Number
40705036012789
Quantity per Package
864
Contains DI Package
10705036012788
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 |