Solitaire™ Platinum

GUDID 00847536034792

STENT SFR3-6-40-10 V06 ENHANCED

Micro Therapeutics, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00847536034792
• NIH Device Record Key: 5fe1fb94-1704-454b-b04a-73853673ce30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire™ Platinum
• Version Model Number: SFR3-6-40-10
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536034792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181186

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: 2019-03-25
• Device Publish Date: 2019-03-15

On-Brand Devices [Solitaire™ Platinum]

• 00847536034792: STENT SFR3-6-40-10 V06 ENHANCED
• 00847536034785: STENT SFR3-6-24-06 V06 ENHANCED
• 00847536034778: STENT SFR3-6-20-10 V06 ENHANCED
• 00847536034761: STENT SFR3-4-40-10 V06 ENHANCED
• 00847536034754: STENT SFR3-4-20-10 V06 ENHANCED
• 00847536034747: STENT SFR3-4-20-05 V06 ENHANCED