Genesys HTA System M00658001R0

GUDID 08714729809357

Genesys HTA System Control Unit

BOSTON SCIENTIFIC CORPORATION

Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system Extravascular-circulation hyperthermia system

• Primary Device ID: 08714729809357
• NIH Device Record Key: e5b31252-10c3-4341-9265-25ba3b36654c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesys HTA System
• Version Model Number: M00658001R0
• Catalog Number: M00658001R0
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729809357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000040

FDA Product Code

• MNB: DEVICE, THERMAL ABLATION, ENDOMETRIAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-14
• Device Publish Date: 2014-09-24

On-Brand Devices [Genesys HTA System]

• 08714729809357: Genesys HTA System Control Unit
• 08714729809326: Genesys HTA System Control Unit