TriClip™ TCDS0301-NT

GUDID 05415067047700

G4 Delivery System

ST. JUDE MEDICAL, INC.

Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip Heart valve clip

• Primary Device ID: 05415067047700
• NIH Device Record Key: e90215fc-5331-4a9a-8f5a-7f872acffc70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriClip™
• Version Model Number: TCDS0301-NT
• Catalog Number: TCDS0301-NT
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

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

Device Dimensions

• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter
• Length: 9 Millimeter
• Depth: 4 Millimeter
• Width: 17 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067047700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230007

FDA Product Code

• NPS: Tricuspid valve repair device, percutaneously delivered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [TriClip™]

• 05415067047755: G4 Delivery System
• 05415067047748: Steerable Guide Catheter
• 05415067047731: G4 Delivery System
• 05415067047724: G4 Delivery System
• 05415067047700: G4 Delivery System