Genesys HTA Control Unit

Basic Information

• Brand Name: Genesys HTA Control Unit
• Primary DI: 00850033976014
• Version / Model: M006580010
• Catalog Number: M006580010
• Company Name: Minerva Surgical, Inc.
• Labeler DUNS: 829616478
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-08
• Public Version: 1
• Public Version Date: 2022-06-16
• Public Version Status: New
• Public Device Record Key: 5c370c16-9acd-406a-804a-af458606faa0

Device Description

Genesys HTA 115V Control Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
MNB	Device, Thermal Ablation, Endometrial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58863	Circulating-fluid endometrial-ablation control unit	A hand-held, electrically-powered device designed to produce and regulate heat in a circulating fluid for ablation (typically at a temperature of approximately 150°C) of the interior lining of the uterus (endometrium) for the treatment of dysfunctional uterine bleeding (menorrhagia). It is intended to be used with a disposable catheter component which circulates the heated fluid. It typically provides computerized control of treatment settings, including time, pressure, and temperature, and consists of an LCD user-interface to display treatment stage information and controls to initiate treatment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033976014	GS1
Previous	08714729809326	GS1

Customer Contacts

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