SpiderFX™

GUDID 00821684068106

EP SPD2-US-030-320 SPIDER FX V03

Covidien LP

Embolic protection filtering guidewire

• Primary Device ID: 00821684068106
• NIH Device Record Key: 29ea9f7a-49cd-48af-a8a0-c01310b07a59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiderFX™
• Version Model Number: SPD2-US-030-320
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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

Device Dimensions

• Length: 320 Centimeter
• Length: 320 Centimeter
• Length: 320 Centimeter
• Length: 320 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684068106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111010

FDA Product Code

• NTE: Temporary Carotid Catheter for Embolic Capture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-04-22

On-Brand Devices [SpiderFX™]

• 00821684068380: EP SPD2-US-070-320 SPIDER FX V04
• 00821684068373: EP SPD2-US-070-190 SPIDER FX V04
• 00821684068366: EP SPD2-US-060-320 SPIDER FX V04
• 00821684068359: EP SPD2-US-060-190 SPIDER FX V04
• 00821684068342: EP SPD2-US-050-320 SPIDER FX V04
• 00821684068335: EP SPD2-US-050-190 SPIDER FX V04
• 00821684068328: EP SPD2-US-040-320 SPIDER FX V04
• 00821684068311: EP SPD2-US-040-190 SPIDER FX V04
• 00821684068304: EP SPD2-US-030-320 SPIDER FX V04
• 00821684068298: EP SPD2-US-030-190 SPIDER FX V04
• 00821684068106: EP SPD2-US-030-320 SPIDER FX V03