Genesys HTA ProCerva M006580210

GUDID 08714729809463

Procedure Set

BOSTON SCIENTIFIC CORPORATION

Extravascular-circulation hyperthermia system

• Primary Device ID: 08714729809463
• NIH Device Record Key: f421e10a-af6d-41cc-b1a0-059b67efd4dd
• Commercial Distribution Discontinuation: 2021-01-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Genesys HTA ProCerva
• Version Model Number: M006580210
• Catalog Number: M006580210
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729809456 [Primary]
GS1	08714729809463 [Package]; Contains: 08714729809456; Package: [5 Units]; Discontinued: 2021-01-19; Not in Commercial Distribution

FDA Product Code

• MNB: DEVICE, THERMAL ABLATION, ENDOMETRIAL

Sterilization

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

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

[08714729809463]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-20
• Device Publish Date: 2014-09-24

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• 00191506047207 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506047221 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506055073 - FARASTAR™: 2026-01-28 Inter-Connection Box
• 00191506057688 - FARASTAR™: 2026-01-28 Pulsed Field Ablation Generator
• 08714729780489 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter
• 08714729780496 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter