Duns Number:829616478
Device Description: Symphion Operative Hysteroscopy System Fluid Management Accessories for use with Symphion Symphion Operative Hysteroscopy System Fluid Management Accessories for use with Symphion Controller
Catalog Number
FG-0202
Brand Name
Symphion Fluid Management Accessories
Version/Model Number
FG-0202
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
PGT
Product Code Name
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Public Device Record Key
988e25e4-5af2-4bf8-9710-b0ac8d95750c
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 |