Solitaire™ X

GUDID 00847536034723

STENT SFR4-6-24-06 V01 US

Micro Therapeutics, Inc.

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• Primary Device ID: 00847536034723
• NIH Device Record Key: 5222de7d-b51d-4cb4-ac49-a1149131d507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire™ X
• Version Model Number: SFR4-6-24-06
• 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
• 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 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536034723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181807

FDA Product Code

• POL: Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

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: 2019-05-07
• Device Publish Date: 2019-04-29

On-Brand Devices [Solitaire™ X]

• 00847536034730: STENT SFR4-6-40-10 V01 US
• 00847536034723: STENT SFR4-6-24-06 V01 US
• 00847536034716: STENT SFR4-6-20-10 V01 US
• 00847536034709: STENT SFR4-4-40-10 V01 US
• 00847536034693: STENT SFR4-4-20-10 V01 US
• 00847536034686: STENT SFR4-4-20-05 V01 US
• 00763000425739: STENT SFR4-6-40-10 V03 SOLITIARE4
• 00763000425715: STENT SFR4-6-24-06 V03 SOLITIARE4
• 00763000425692: STENT SFR4-6-20-10 V03 SOLITIARE4
• 00763000425678: STENT SFR4-4-40-10 V03 SOLITIARE4
• 00763000425654: STENT SFR4-4-20-10 V03 SOLITIARE4
• 00763000425630: STENT SFR4-4-20-05 V03 SOLITIARE4
• 00763000367626: STENT SFR4-3-40-10 V01 3X40
• 00763000367619: STENT SFR4-3-20-10 V01 3X20