Genesys HTA ProCerva M006580210

GUDID 00850033976038

Procedure Set including Procedure Sheath, Cassette, Drainage Bag

Minerva Surgical, Inc.

Circulating-fluid endometrial-ablation catheter

• Primary Device ID: 00850033976038
• NIH Device Record Key: a289ace3-e8e8-4813-87c2-d92737c9ef52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesys HTA ProCerva
• Version Model Number: M006580210
• Catalog Number: M006580210
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033976038 [Primary]
GS1	00850033976045 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	08714729809456 [Previous]

FDA Product Code

• MNB: Device, Thermal Ablation, Endometrial

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

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 Hysteroscope: 2024-10-15 Disposable Electronic Hysteroscope For Use with HERizon Medical Endoscope Image Processor
• 10850033976271 - HERizon Disposable Endoscopic Forceps - Biopsy: 2024-10-15 Disposable Endoscopic Forceps - Biopsy
• 10850033976288 - HERizon Disposable Endoscopic Forceps - Foreign Body Grasper: 2024-10-15 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 Tooth: 2024-10-15 Disposable Endoscopic Forceps - Inverted Tooth
• 10850033976318 - HERizon Disposable Endoscopic Scissors: 2024-10-15 Disposable Endoscopic Scissors
• 00850033976236 - INFINITY Fluid Management Accessory: 2024-08-20 Symphion Operative Hysteroscopy System, Fluid Management with filter for recirculation. For use with Symphion Controller.