ENT NIM Electrode

GUDID 00763000891862

PROBE 8225275 BALL TIP 1MM ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system

• Primary Device ID: 00763000891862
• NIH Device Record Key: f5a03f9f-ac06-47e8-a0d9-37d0beffe6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENT NIM Electrode
• Version Model Number: 8225275
• 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
• 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	00763000891862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992869

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

[00763000891862]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [ENT NIM Electrode]

• 00763000891879: PROBE 8225276 BALL TIP 2.3MM ROHS
• 00763000891862: PROBE 8225275 BALL TIP 1MM ROHS