GUDID 00613994315960

BUR GUARD 3318601 STIMULATE W/IRR ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered Nerve-locating system, line-powered Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system

• Primary Device ID: 00613994315960
• NIH Device Record Key: 290c6946-3e6f-4367-bff3-3c7f0e87c761
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3318601
• 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994315960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063305

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-29

Devices Manufactured by MEDTRONIC XOMED, INC.

• 20763000281643 - Donldsn: 2024-04-30 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL
• 20763000282992 - Shah: 2024-04-29 VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
• 00763000849573 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE
• 00763000849580 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE-RF REFURBISHED
• 00763000882389 - NIM: 2024-02-12 EMG TUBE 8229306 NIM STD 6MM ROHS
• 00763000882396 - NIM: 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000882402 - NIM: 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000882419 - NIM: 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS