X-pedionTM

GUDID 00847536004719

103-0605-200 X-PEDION 10

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual

• Primary Device ID: 00847536004719
• NIH Device Record Key: 4385d431-1272-4b79-bc1d-7239bf9b39ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-pedionTM
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536004719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124007

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

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

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

[00847536004719]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-16

On-Brand Devices [X-pedionTM]

• 00847536006362: 203-0602-200 XPEDION14 GUIDEWIRE 200CM
• 00847536006355: 203-0602-200 XPEDION14 GUIDEWIRE 200CM
• 00847536006348: 203-0602-200 X-PEDION 14 GUIDEWIRE
• 00847536004733: 103-0605-200 XPEDION10 GWIRE 200CM ATH
• 00847536004726: 103-0605-200 XPEDION10 GWIRE 200CM ATH
• 00847536004719: 103-0605-200 X-PEDION 10