TrailBlazer™

GUDID 20763000762791

PS SC-035-065 TRAILBLAZER V06

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 20763000762791
• NIH Device Record Key: 62a1d608-ab8c-4eb6-befd-69df059c07fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrailBlazer™
• Version Model Number: SC-035-065
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0
• Length: 65 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.
• Special Storage Condition, Specify: Between 0 and 0 *Store the device in a dry area away from sunlight.Do not store catheters where they are directly exposed to organic solvents, ionizing radiation, or ultraviolet light.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000762797 [Primary]
GS1	20763000762791 [Package]; Contains: 00763000762797; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092299

FDA Product Code

• DQY: Catheter, percutaneous

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: 2024-01-08
• Device Publish Date: 2023-12-30

On-Brand Devices [TrailBlazer™]

• 20763000762821: PS SC-035-150 TRAILBLAZER V06
• 20763000762814: PS SC-035-135 TRAILBLAZER V06
• 20763000762807: PS SC-035-090 TRAILBLAZER V06
• 20763000762791: PS SC-035-065 TRAILBLAZER V06
• 20763000762784: PS SC-018-150 TRAILBLAZER V06
• 20763000762777: PS SC-018-135 TRAILBLAZER V06
• 20763000762760: PS SC-018-090 TRAILBLAZER V06
• 20763000762753: PS SC-014-150 TRAILBLAZER V06
• 20763000762746: PS SC-014-135 TRAILBLAZER V06
• 20763000770383: PS ASC-035-150 TRAILBLAZER ANGLED V04
• 20763000770376: PS ASC-035-135 TRAILBLAZER ANGLED V04
• 20763000770369: PS ASC-035-090 TRAILBLAZER ANGLED V04
• 20763000770352: PS ASC-035-065 TRAILBLAZER ANGLED V04
• 20763000770345: PS ASC-018-150 TRAILBLAZER ANGLED V04
• 20763000770338: PS ASC-018-135 TRAILBLAZER ANGLED V04
• 20763000770321: PS ASC-018-090 TRAILBLAZER ANGLED V04
• 20763000770314: PS ASC-014-150 TRAILBLAZER ANGLED V04
• 20763000770307: PS ASC-014-135 TRAILBLAZER ANGLED V04
• 20763000770291: PS ASC-014-090 TRAILBLAZER ANGLED V04