OPTISi™ 1014941

GUDID 05415067036810

Next Doc Holster FRU

ST. JUDE MEDICAL, INC.

Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system Coronary optical coherence tomography system

• Primary Device ID: 05415067036810
• NIH Device Record Key: 87d7a901-3607-4aae-b874-a2d5e1efcb4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTISi™
• Version Model Number: 1014941
• Catalog Number: 1014941
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067036810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210458

FDA Product Code

• NQQ: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-30
• Device Publish Date: 2021-06-22

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067049414 - Entrant™: 2024-05-03 VR Implantable Cardioverter Defibrillator
• 05415067049421 - Gallant™: 2024-05-03 VR Implantable Cardioverter Defibrillator
• 05415067049469 - Entrant™: 2024-05-03 DR Implantable Cardioverter Defibrillator
• 05415067049476 - Gallant™: 2024-05-03 DR Implantable Cardioverter Defibrillator
• 05415067049513 - Entrant™: 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
• 05415067049520 - Gallant™: 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
• 05415067047700 - TriClip™: 2024-04-22 G4 Delivery System
• 05415067047724 - TriClip™: 2024-04-22 G4 Delivery System