Duns Number:492888563
Device Description: Device for use in combination with the symphonX Introducer during minimally invasive abdom Device for use in combination with the symphonX Introducer during minimally invasive abdominal laparoscopic surgical procedures
Catalog Number
314-201
Brand Name
symphonX™
Version/Model Number
Hub Cap & Sealing Unit
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
03c11ecb-75dc-4e79-b052-afb2ede30aa1
Public Version Date
September 14, 2020
Public Version Number
7
DI Record Publish Date
February 15, 2017
Package DI Number
08719324463072
Quantity per Package
12
Contains DI Package
08719324463171
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 |