Nexframe®

GUDID 00643169214811

ACCY DB-2040 NEXFRAME NEW QTS FACILTY US

MEDTRONIC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00643169214811
• NIH Device Record Key: 0126f8c9-79b1-4a18-b69a-3e4890388bb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexframe®
• Version Model Number: DB-2040
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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: 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 -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169214811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012366

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-18

On-Brand Devices [Nexframe®]

• 00643169214828: ACCY DB-2040-ST NEXFRAME STRYKER US MKT
• 00643169214811: ACCY DB-2040 NEXFRAME NEW QTS FACILTY US
• 00643169214804: ACCESSORY DB-2040 NEXFRAME MDD GLBL MKT