Symphion Fluid Deficit Readout

Basic Information

• Brand Name: Symphion Fluid Deficit Readout
• Primary DI: 00850033976243
• Version / Model: FG-FDR1
• Catalog Number: FG-FDR1
• Company Name: Minerva Surgical, Inc.
• Labeler DUNS: 829616478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-12
• Public Version: 1
• Public Version Date: 2024-08-20
• Public Version Status: New
• Public Device Record Key: a2e93166-2cec-4610-a48e-9407ef4a25d8

Device Description

Symphion Operative Hysteroscopy System Fluid Deficit Readout For use with Symphion Controller SW Version 3.0.0 or higher. Contents: (1) Display Controller (2) Power Supply (3) Power Cord

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PGT	Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar	Obstetrics/Gynecology	884.1710	2
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	884.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63308	Electrolytic-plasma electrosurgical system	An assembly of devices intended to use radio-frequency (RF) alternating current in a bipolar configuration to excite electrolytes within a solution (typically saline) to create a focused, charged plasma sphere for cutting and coagulation of soft tissues during an endoscopic or open surgical procedure. The assembly includes a mains electricity (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and bipolar electrodes to apply the energy to the surgical site. It is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system) and is not intended for argon-enhanced electrosurgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033976243	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]