Bipolar Stimulating Probe

GUDID 00763000842550

PROBE 8225401 5PK SD-SD BIPOL STIM ROHS

MEDTRONIC XOMED, INC.

Nerve-locating system probe, single-use

• Primary Device ID: 00763000842550
• NIH Device Record Key: 75ea73c4-8be0-4614-ac51-d5ddbdde5a02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Stimulating Probe
• Version Model Number: 8225401
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000842550 [Unit of Use]
GS1	20763000842554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934426

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-04
• Device Publish Date: 2024-10-26

On-Brand Devices [Bipolar Stimulating Probe]

• 00763000842567: PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
• 00763000842550: PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
• 00763000842543: PROBE 8225351 5PK CONCEN BIPO STIM ROHS