Genesys HTA System

Basic Information

• Brand Name: Genesys HTA System
• Primary DI: 08714729809357
• Version / Model: M00658001R0
• Catalog Number: M00658001R0
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 6
• Public Version Date: 2021-05-20
• Public Version Status: Update
• Public Device Record Key: e5b31252-10c3-4341-9265-25ba3b36654c
• Distribution End Date: 2021-01-19

Device Description

Genesys HTA System 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
40784	Extravascular-circulation hyperthermia system	An assembly of devices designed to produce and control heated fluids circulated within a vessel applied to the body (e.g., vest, mattress, jacket, band, pad, body wrap, catheter, probe) for systemic or localized heating to treat malignant tumours, benign growths, or other disease-related conditions. It is typically a computer-controlled configuration used for curative or palliative treatment by causing the temperature of the whole body, localized areas, or targeted organs to rise to temperatures greater than 43? Celsius. It is typically used in an oncology department.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729809357	GS1