Duns Number:832920099
Device Description: A sterile, metallic, non-bio-absorbable clasp designed to be implanted around a blood vess A sterile, metallic, non-bio-absorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy, or a tissue bundle for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries.
Catalog Number
60415
Brand Name
Titanium Ligation Clip
Version/Model Number
60415
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
K091060,K091060,K091060
Product Code
FZP
Product Code Name
Clip, Implantable
Public Device Record Key
9c125629-e793-4255-a117-60099a64fb94
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
60857596005085
Quantity per Package
18
Contains DI Package
50857596005088
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |