Duns Number:829616478
Device Description: Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller - Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller - RefurbishedContents:(1) Hysteroscope(1) Storz Scope Adapter(1) Wolf Scope Adapter(1) Working Channel Brush(1) Fluid Channel Brush
Catalog Number
FG-0703-R
Brand Name
Symphion 6.3 Hysteroscope - Refurbished
Version/Model Number
FG-0703-R
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
-
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
HIH
Product Code Name
Hysteroscope (And Accessories)
Public Device Record Key
5d3d678d-73b3-4548-92c7-a3dc9b1626c1
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 |