TrailBlazer™

GUDID 20763000762807

PS SC-035-090 TRAILBLAZER V06

MEDTRONIC, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

Primary Device ID	20763000762807
NIH Device Record Key	3253eb6c-0b41-497c-9955-e20804c4e6e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	TrailBlazer™
Version Model Number	SC-035-090
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	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 Centimeter
Device Size Text, specify	0
Length	90 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	00763000762803 [Primary]
GS1	20763000762807 [Package] Contains: 00763000762803 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

Trademark Results [TrailBlazer]

Mark Image Registration \| Serial	Company Trademark Application Date
TRAILBLAZER 98469001 not registered Live/Pending	GROW COACHING SOLUTIONS, LLC 2024-03-26
TRAILBLAZER 98456859 not registered Live/Pending	Aurora Cooperative Elevator Company 2024-03-19
TRAILBLAZER 98385011 not registered Live/Pending	Generations of Sonoma, LLC 2024-01-31
TRAILBLAZER 98351133 not registered Live/Pending	Tarrant County College District 2024-01-10
TRAILBLAZER 98303111 not registered Live/Pending	TP-Holiday Group Limited 2023-12-07
TRAILBLAZER 98299673 not registered Live/Pending	Trailblazer Women's Wellness, PLLC 2023-12-05
TRAILBLAZER 98180580 not registered Live/Pending	Spinal Elements, Inc. 2023-09-14
TRAILBLAZER 97722935 not registered Live/Pending	Athletic Brewing Company LLC 2022-12-19
TRAILBLAZER 97670112 not registered Live/Pending	Trailblazer Energy Resources, LLC 2022-11-09
TRAILBLAZER 90787630 not registered Live/Pending	Made In Nature, LLC 2021-06-22
TRAILBLAZER 90274398 not registered Live/Pending	Intabio, Inc. 2020-10-23
TRAILBLAZER 88828665 not registered Live/Pending	eSite Analytics, Inc. 2020-03-10