SilverSpeedTM

GUDID 00847536004382

103-0601-200 SILVERSPEED10 GWIRE ATH

Micro Therapeutics, Inc.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

• Primary Device ID: 00847536004382
• NIH Device Record Key: 4d9c510b-e9d4-4b41-aa3a-ea751c4cd0f6
• 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	00847536004382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982543

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

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

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

Ethylene Oxide

[00847536004382]

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