Symphion 6.3 Hysteroscope - Refurbished FG-0703-R

GUDID 00850033976137

Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller - Refurbished Contents: (1) Hysteroscope (1) Storz Scope Adapter (1) Wolf Scope Adapter (1) Working Channel Brush (1) Fluid Channel Brush

Minerva Surgical, Inc.

Rigid optical hysteroscope
Primary Device ID00850033976137
NIH Device Record Key5d3d678d-73b3-4548-92c7-a3dc9b1626c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSymphion 6.3 Hysteroscope - Refurbished
Version Model NumberFG-0703-R
Catalog NumberFG-0703-R
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com
Phone855-646-7874
Emailcustomerservice@minervasurgical.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033976137 [Primary]
GS108714729905806 [Previous]

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00850033976137]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-11
Device Publish Date2022-05-03

Devices Manufactured by Minerva Surgical, Inc.

00850033976250 - HERizon Medical Endoscope Image Processor 2024-10-15 Medical Endoscope Image Processor For Use with HERizon Disposable Electronic Hysteroscope.
10850033976264 - HERizon Disposable Electronic Hysteroscope2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor
10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy2024-10-15 Disposable Endoscopic Forceps - Biopsy
10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper2024-10-15 Disposable Endoscopic Forceps - Foreign Body Grasper
10850033976295 - HERizon Disposable Endoscopic Forceps – Alligator 2024-10-15 Disposable Endoscopic Forceps – Alligator
10850033976301 - HERizon Disposable Endoscopic Forceps - Inverted Tooth2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth
10850033976318 - HERizon Disposable Endoscopic Scissors2024-10-15 Disposable Endoscopic Scissors
00850033976236 - INFINITY Fluid Management Accessory2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.