GUDID 00802526610615

STERILZABLE TELEMETRY WAND

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526610615
• NIH Device Record Key: c3733906-0265-4d31-bfe7-3b628df26fd5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6395
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00802526610615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910077

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

Sterilization

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

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

[00802526610615]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-13
• Device Publish Date: 2020-05-05

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506043216 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043223 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043698 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043704 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043711 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator