SolitaireTM

GUDID 00847536020535

STENT SFR3-4-40-10V01 US

Micro Therapeutics, Inc.

Thrombectomy suction catheter

• Primary Device ID: 00847536020535
• NIH Device Record Key: 47fb1167-acda-4796-b9fe-4071b6e04893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SolitaireTM
• Version Model Number: SFR3-4-40-10
• 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	00847536020535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153071

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

Sterilization

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

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

Ethylene Oxide

[00847536020535]

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: 2017-09-24

On-Brand Devices [SolitaireTM]

• 00847536027060: STENT SFR3-6-24-06 V01
• 00847536027053: STENT SFR3-4-20-05 V01
• 00847536020559: STENT SFR3-6-40-10V01 US
• 00847536020542: STENT SFR3-6-20-10V01 US
• 00847536020535: STENT SFR3-4-40-10V01 US
• 00847536020528: STENT SFR3-4-20-10V01 US