NIM™

GUDID 00721902454301

FUSE 8250615 PAT INTFC REPLCMNT KIT 32MA

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered

• Primary Device ID: 00721902454301
• NIH Device Record Key: 2c3c7e87-e25c-4984-af9f-18bf0e66e37e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM™
• Version Model Number: 8250615
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902454301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982595

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

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

On-Brand Devices [NIM™]

• 00721902454301: FUSE 8250615 PAT INTFC REPLCMNT KIT 32MA
• 00763000631598: MUTING PROBE 8220325 NIM ROHS