SilverSpeedTM

GUDID 00847536004375

103-0601-200 SILVERSPEED 010

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual

• Primary Device ID: 00847536004375
• NIH Device Record Key: 78c999cb-c9e0-4783-b7d2-8afcf807f6c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilverSpeedTM
• Version Model Number: 103-0601-200
• 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	00847536004375 [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

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

Ethylene Oxide

[00847536004375]

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 [SilverSpeedTM]

• 00847536004696: 103-0603-200 SIVERSPEED 16 GWIRE ATH
• 00847536004689: 103-0603-200 SIVERSPEED 16 GWIRE ATH
• 00847536004672: 103-0603-200 SILVERSPEED 16
• 00847536004566: 103-0602-200 SILVERSPEED14 GWIRE ATH
• 00847536004559: 103-0602-200 SILVERSPEED14 GWIRE ATH
• 00847536004542: 103-0602-200 SILVERSPEED14 GWIRE 200CM
• 00847536004528: 103-0602-175 SILVERSPEED14 GWIRE ATH
• 00847536004511: 103-0602-175 SILVERSPEED14 GWIRE ATH
• 00847536004504: 103-0602-175 SILVERSPEED 14 175CM
• 00847536004399: 103-0601-200 SILVERSPEED10 GWIRE ATH
• 00847536004382: 103-0601-200 SILVERSPEED10 GWIRE ATH
• 00847536004375: 103-0601-200 SILVERSPEED 010