Symphion 6.3 Hysteroscope FG-0703

GUDID 00850033976120

Symphion Operative Hysteroscopy System 6.3 Hysteroscope for use with Symphion Controller 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 Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope Rigid optical hysteroscope

• Primary Device ID: 00850033976120
• NIH Device Record Key: b6392260-3c43-4563-8dda-8eb1a65fa251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphion 6.3 Hysteroscope
• Version Model Number: FG-0703
• Catalog Number: FG-0703
• Company DUNS: 829616478
• Company Name: Minerva Surgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com
• Phone: 855-646-7874
• Email: customerservice@minervasurgical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033976120 [Primary]
GS1	08714729863670 [Previous]

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00850033976120]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-11
• Device Publish Date: 2022-05-03

Devices Manufactured by Minerva Surgical, Inc.

• 00850033976168 - Genesys HTA Scope Adapter, STORZ: 2022-10-27 STORZ Scope Adapter, for use only with Genesys HTA System
• 00850033976175 - Genesys HTA Scope Adapter, WOLF: 2022-10-27 WOLF Scope Adapter, for use only with Genesys HTA System
• 00850033976182 - Genesys HTA Scope Adapter, ACMI: 2022-10-27 ACMI Scope Adapter, for use only with Genesys HTA System
• 00850033976199 - Genesys HTA Scope Adapter, OLYMPUS: 2022-10-27 OLYMPUS Scope Adapter, for use only with Genesys HTA System
• 00850033976014 - Genesys HTA Control Unit: 2022-06-16 Genesys HTA 115V Control Unit
• 00850033976021 - Genesys HTA Control Unit - Refurbished: 2022-06-16 Genesys HTA 115V Control Unit (Refurbished)
• 00850033976038 - Genesys HTA ProCerva: 2022-06-16 Procedure Set including Procedure Sheath, Cassette, Drainage Bag
• 00850033976205 - Genesys HTA System Pedestal: 2022-06-16 IV Pole, Tool Kit