INFINITY Fluid Management Accessory FG-0204

GUDID 00850033976236

Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.

Minerva Surgical, Inc.

Electrolytic-plasma electrosurgical system
Primary Device ID00850033976236
NIH Device Record Key7bef214e-0b47-4463-a330-532786f6458c
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITY Fluid Management Accessory
Version Model NumberFG-0204
Catalog NumberFG-0204
Company DUNS829616478
Company NameMinerva Surgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com
Phone855-646-7674
Emailcustomerservice@minervasurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033976236 [Primary]

FDA Product Code

PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

Devices Manufactured by Minerva Surgical, Inc.

00850033976236 - INFINITY Fluid Management Accessory2024-08-20Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.
00850033976236 - INFINITY Fluid Management Accessory2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.
00850033976243 - Symphion Fluid Deficit Readout2024-08-20 Symphion Operative Hysteroscopy System Fluid Deficit Readout For use with Symphion Controller SW Version 3.0.0 or higher. Conten
00850033976168 - Genesys HTA Scope Adapter, STORZ2022-10-27 STORZ Scope Adapter, for use only with Genesys HTA System
00850033976175 - Genesys HTA Scope Adapter, WOLF2022-10-27 WOLF Scope Adapter, for use only with Genesys HTA System
00850033976182 - Genesys HTA Scope Adapter, ACMI2022-10-27 ACMI Scope Adapter, for use only with Genesys HTA System
00850033976199 - Genesys HTA Scope Adapter, OLYMPUS2022-10-27 OLYMPUS Scope Adapter, for use only with Genesys HTA System
00850033976014 - Genesys HTA Control Unit2022-06-16 Genesys HTA 115V Control Unit
00850033976021 - Genesys HTA Control Unit - Refurbished2022-06-16 Genesys HTA 115V Control Unit (Refurbished)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.