Solitaire ™ Platinum

GUDID 00763000425517

STENT SFR3-6-24-06 V07 SOLITAIRE3

Micro Therapeutics, Inc.

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• Primary Device ID: 00763000425517
• NIH Device Record Key: 154d7a82-d108-4aa6-a187-0eed8457e2cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire ™ Platinum
• Version Model Number: SFR3-6-24-06
• 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

Device Dimensions

• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter
• Stent Diameter: 6 Millimeter
• Stent Length: 24 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store product in a dry, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000425517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181186

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

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: 2021-03-22
• Device Publish Date: 2021-03-12

On-Brand Devices [Solitaire ™ Platinum]

• 00763000425579: STENT SFR3-6-40-10 V07 SOLITAIRE3
• 00763000425517: STENT SFR3-6-24-06 V07 SOLITAIRE3
• 00763000425456: STENT SFR3-4-20-05 V07 SOLITAIRE3
• 00763000425395: STENT SFR3-6-20-10 V07 SOLITAIRE3
• 00763000425333: STENT SFR3-4-40-10 V07 SOLITAIRE3
• 00763000425272: STENT SFR3-4-20-10 V07 SOLITAIRE3