Duns Number:492888563
Device Description: Device for grasping tissue; to be used in combination with the symphonX Handle, Handle wit Device for grasping tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.
Catalog Number
314-001
Brand Name
symphonX™
Version/Model Number
Grasper
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
614417d9-6fb8-4e16-a01c-13b1ab02391a
Public Version Date
September 14, 2020
Public Version Number
9
DI Record Publish Date
February 15, 2017
Package DI Number
08719324463010
Quantity per Package
6
Contains DI Package
08719324463119
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 |