X-Pedion

GUDID 00763000294113

GUIDEWIRE 103-0605-200 V08 X-PEDION-10

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual

• Primary Device ID: 00763000294113
• NIH Device Record Key: e02c4241-bf0f-4397-8c49-b5e43407131e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Pedion
• Version Model Number: 103-0605-200
• 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: 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
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Stored in a dry place, away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000294113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193548
• Premarket Notification: K201690

FDA Product Code

• DQX: Wire, guide, catheter

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: 2020-08-10
• Device Publish Date: 2020-07-31

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