TrailBlazer™

Basic Information

• Brand Name: TrailBlazer™
• Primary DI: 00643169996168
• Version / Model: SC-035-135
• Company Name: EV3, INC
• Labeler DUNS: 117446916
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-15
• Public Version: 7
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: c87a6dd5-063f-49d2-a7ad-4bd4e2a191ef
• Distribution End Date: 2019-10-21

Device Description

PS SC-035-135 TRAILBLAZER V04

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	CATHETER, PERCUTANEOUS	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20643169996162	GS1	PK	5	Not in Commercial Distribution	2019-10-21
Primary	00643169996168	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092299	000

Device Sizes

Type	Value	Unit	Text
Length	135.0	Centimeter
Outer Diameter	0.89	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Store in Direct Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry