Duns Number:492888563
Device Description: Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clip Device for use as a delivery system for Hem-o-lok® ML Non-absorbable Polymer Ligation Clips; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
Catalog Number
314-004
Brand Name
symphonX™
Version/Model Number
Clip Applier
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 10, 2020
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
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
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
918058d2-4a96-443d-996a-784f7f4f482f
Public Version Date
August 24, 2021
Public Version Number
9
DI Record Publish Date
February 15, 2017
Package DI Number
08719324463041
Quantity per Package
6
Contains DI Package
08719324463140
Package Discontinue Date
September 10, 2020
Package Status
Not in Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |