Duns Number:829616478
Device Description: Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Content Symphion Operative Hysteroscopy System Controller with Integrated Fluid Management Contents:(1) Symphion Controller(1) Power Cord(1) Footswitch(1) Saline Pole
Catalog Number
FG-0612
Brand Name
Symphion Controller
Version/Model Number
FG-0612
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
PGT
Product Code Name
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Public Device Record Key
fd584ad3-8849-4f92-965a-700fa0b7674b
Public Version Date
May 11, 2022
Public Version Number
1
DI Record Publish Date
May 03, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 4 |