GUDID 00613994334565

CABLE 68005YN EGM 18L

MEDTRONIC, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 00613994334565
• NIH Device Record Key: f7e8cb89-2f9d-4be8-b310-c10e1dc18c5a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 68005YN
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• 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: false
• 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

Device Dimensions

• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter
• Length: 457 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the cable to storage temperatures above 65°C or below -35°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994334565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060400

FDA Product Code

• OCL: Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-05-02

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• 20763000651798 - Aortic Punch: 2025-03-31 Aortic Punch APU450 - 5.0mm punch size