NIM-ECLIPSE®

GUDID 00763000102388

COMPUTER 945NCCPUE4 LAPTOP

MEDTRONIC SOFAMOR DANEK, INC.

Laptop/tablet computer Laptop/tablet computer

• Primary Device ID: 00763000102388
• NIH Device Record Key: ff278e6c-bc5f-435f-8717-6014f97b3a17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIM-ECLIPSE®
• Version Model Number: 945NCCPUE4
• 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
• 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
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000102388 [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: 2018-08-30
• Device Publish Date: 2018-07-30

On-Brand Devices [NIM-ECLIPSE®]

• 00643169944275: COMPUTER 945NWCPUE4 DESKTOP
• 00643169438187: COMPUTER 945NWCPUE4 DESKTOP
• 00763000102388: COMPUTER 945NCCPUE4 LAPTOP
• 00763000102371: COMPUTER 945NWCPUE4 DESKTOP