SpiderFX SPD2-US-070-320

GUDID 00821684040379

Embolic Protection Device

Covidien LP

Embolic protection filtering guidewire Embolic protection filtering guidewire

• Primary Device ID: 00821684040379
• NIH Device Record Key: a8e8bf89-1f36-4c73-9c61-d5923bd2c415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpiderFX
• Version Model Number: SPD2-US-070-320
• Catalog Number: SPD2-US-070-320
• Company DUNS: 968903703
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: true
• 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

Device Dimensions

• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684040379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063785

FDA Product Code

• NFA: Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection

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: 2015-10-16

On-Brand Devices [SpiderFX]

• 00821684040522: Embolic Protection Device
• 00821684040515: Embolic Protection Device
• 00821684040508: Embolic Protection Device
• 00821684040492: Embolic Protection Device
• 00821684040485: Embolic Protection Device
• 00821684040379: Embolic Protection Device
• 00821684040362: Embolic Protection Device
• 00821684040355: Embolic Protection Device
• 00821684040348: Embolic Protection Device
• 00821684040331: Embolic Protection Device