AMPLATZ GOOSE NECK™

GUDID 00763000225346

ACCESSORY MC4001 ANGIO CATHETERS V01

EV3, INC

Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare

• Primary Device ID: 00763000225346
• NIH Device Record Key: 47f5b925-90b5-4f25-b2ed-cf25010a438b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLATZ GOOSE NECK™
• Version Model Number: MC4001
• Company DUNS: 117446916
• Company Name: EV3, 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

Device Dimensions

• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter
• Catheter Inner Diameter: 1.02 Millimeter
• Catheter Working Length: 48 Centimeter
• Outer Diameter: 1.33 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store away from sunlight at room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000225346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972511

FDA Product Code

• DXE: Catheter, embolectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-07-08
• Device Publish Date: 2020-11-13

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