Solitaire™

GUDID 00847536033986

STENT SFR3-6-40-10 V04 US

Micro Therapeutics, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00847536033986
• NIH Device Record Key: f902fdd1-068f-480e-ac7f-223da4c07881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire™
• 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	00847536033986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160641

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: 2018-08-13
• Device Publish Date: 2018-07-13

On-Brand Devices [Solitaire™]

• 00847536034044: STENT SFR3-6-40-10 V05 EXTENDED IFU
• 00847536034037: STENT SFR3-6-24-06 V05 EXTENDED IFU
• 00847536034020: STENT SFR3-4-20-05 V05 EXTENDED IFU
• 00847536034013: STENT SFR3-6-20-10 V05 EXTENDED IFU
• 00847536034006: STENT SFR3-4-40-10 V05 EXTENDED IFU
• 00847536033993: STENT SFR3-4-20-10 V05 EXTENDED IFU
• 00847536033986: STENT SFR3-6-40-10 V04 US
• 00847536033979: STENT SFR3-6-24-06 V04 US
• 00847536033962: STENT SFR3-4-20-05 V04 US
• 00847536033955: STENT SFR3-6-20-10 V04 US
• 00847536033948: STENT SFR3-4-40-10 V04 US
• 00847536033931: STENT SFR3-4-20-10 V04 US
• 00847536029286: STENT SFR3-4-40-10 V02 US
• 00847536029279: STENT SFR3-4-20-10 V02 US