TriClip™ TSGC0201

GUDID 05415067047748

Steerable Guide Catheter

ST. JUDE MEDICAL, INC.

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• Primary Device ID: 05415067047748
• NIH Device Record Key: 4611e760-8952-47bf-9b9e-ecaadc3d7c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriClip™
• Version Model Number: TSGC0201
• Catalog Number: TSGC0201
• 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: 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

• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter
• Outer Diameter: 8.4 Millimeter
• Length: 80 Centimeter

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	05415067047748 [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