X-pedion 203-0602-200

GUDID 00836462003224

14 Hydrophilic Guidewire

Micro Therapeutics, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00836462003224
• NIH Device Record Key: 2b1d0cdf-d611-467d-be21-2d0e9bbd84c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-pedion
• Version Model Number: 203-0602-200
• Catalog Number: 203-0602-200
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462003224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001454

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-06

On-Brand Devices [X-pedion]

• 00836462003224: 14 Hydrophilic Guidewire
• 00836462003170: 10 Hydrophilic Guidewire
• 00763000294113: GUIDEWIRE 103-0605-200 V08 X-PEDION-10
• 00763000518929: GUIDEWIRE 103-0605-200 V09 X-PEDION MDR