NIM-Eclipse

GUDID 00763000570279

COMPUTER 945NWCPUE4 DESKTOP

MEDTRONIC SOFAMOR DANEK, INC.

Nerve-locating system

• Primary Device ID: 00763000570279
• NIH Device Record Key: 6f111d17-e812-4125-8ee3-5f492453ed88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM-Eclipse
• Version Model Number: 945NWCPUE4
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000570279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061639

FDA Product Code

• GWF: Stimulator, electrical, evoked response

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [NIM-Eclipse]

• 00763000384197: COMPUTER 945NWCPUE4 DESKTOP
• 00763000384180: COMPUTER 945NCCPUE4 NOTEBOOK
• 00763000570279: COMPUTER 945NWCPUE4 DESKTOP
• 00763000570262: COMPUTER 945NCCPUE4 NOTEBOOK