REACT™

GUDID 00847536041967

CATHETER REACT-68 V03 eIFU

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00847536041967
• NIH Device Record Key: 94b11453-7a49-46de-82d7-9b062d4ce074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REACT™
• Version Model Number: REACT-68
• 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
• 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
• 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
• 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	00847536041967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180715

FDA Product Code

• DQY: Catheter, percutaneous

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: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [REACT™]

• 00847536044197: CATHETER REACT-71 V03 eIFU
• 00847536041967: CATHETER REACT-68 V03 eIFU