IPC

GUDID 00763000402273

MASTER CONSOLE EC300 LEGEND EHS ROHS

MEDTRONIC XOMED, INC.

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 00763000402273
• NIH Device Record Key: fe0d214f-d6fb-4a2c-bcc8-139c7b75d695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IPC
• Version Model Number: EC300
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: false
• Serial Number: true
• 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
• 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

• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000402273 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081277

FDA Product Code

• HBE: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-01
• Device Publish Date: 2021-02-21

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• 00763000842550 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
• 00763000842567 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
• 00763000891862 - ENT NIM Electrode: 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS
• 00763000891879 - ENT NIM Electrode: 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS
• 00763000580483 - ENT NIM Vital: 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS
• 00763000578022 - N/A: 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL