Duns Number:492888563
Device Description: The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Intr The purpose of the symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.
Catalog Number
314-103
Brand Name
symphonX™
Version/Model Number
Introducer Clamp Type B
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
OTJ
Product Code Name
Laparoscopic Single Port Access Device
Public Device Record Key
1cfa65f7-5c5d-41d4-bf9d-00e665a8a969
Public Version Date
September 14, 2020
Public Version Number
4
DI Record Publish Date
May 22, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |