Solitaire 2 SFR2-4-15

GUDID 00836462016378

Revascularization Device

Micro Therapeutics, Inc.

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• Primary Device ID: 00836462016378
• NIH Device Record Key: edb516bf-4d05-4b8b-b051-14028f7021a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solitaire 2
• Version Model Number: SFR2-4-15
• Catalog Number: SFR2-4-15
• 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: true
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Length: 26 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462016378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123378

FDA Product Code

• NRY: CATHETER, THROMBUS RETRIEVER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [Solitaire 2]

• 00847536003323: Revascularization Device
• 00836462016408: SFR2-6-30 SOLITAIRE 2 DEVICE
• 00836462016392: SFR2-6-20 SOLITAIRE 2 DEVICE
• 00836462016385: SFR2-4-20 SOLITAIRE 2 DEVICE
• 00836462016378: Revascularization Device