GUDID 00613994870919

RING RSE1000 ELECTRODE STIM ADAPTER ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered

• Primary Device ID: 00613994870919
• NIH Device Record Key: 376d208f-dd05-4851-81e4-efec1af49724
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RSE1000
• 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: 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
• 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	00613994870919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850108

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

Sterilization

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

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

[00613994870919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-05

Devices Manufactured by MEDTRONIC XOMED, INC.

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• 00763000842567 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
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• 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