FASTRACKER - 10 135109

GUDID 04546540688071

2 Tip Straight Microcatheter

Stryker Corporation

Vascular microcatheter

• Primary Device ID: 04546540688071
• NIH Device Record Key: 3a2203af-6b86-4e5e-aca7-5b2220479343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FASTRACKER - 10
• Version Model Number: M0031351090
• Catalog Number: 135109
• Company DUNS: 042405446
• Company Name: Stryker Corporation
• 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)916-3876
• Email: NVCustomerService@stryker.com

Device Dimensions

• Length: 150 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry, dark place

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540688071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926243

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-21

On-Brand Devices [FASTRACKER - 10]

• 07613252187035: 1 Tip Straight Microcatheter
• 04546540688071: 2 Tip Straight Microcatheter
• 04546540688064: 1 Tip Straight Microcatheter