daVinci Xi

GUDID 00886874110744

SURGEON SIDE CONSOLE, SMART PEDALS

INTUITIVE SURGICAL, INC.

Robotic surgical system

• Primary Device ID: 00886874110744
• NIH Device Record Key: 81ef9c10-03ce-45b0-a831-e3edd99ed741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: daVinci Xi
• Version Model Number: 380677
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874110744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131861

FDA Product Code

• NAY: System,surgical,computer controlled instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 42
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-07-08

On-Brand Devices [daVinci Xi]

• 00886874115510: VISION SIDE SYSTEM, RECERTIFIED
• 00886874115503: SURGEON SIDE CONSOLE, RECERTIFIED
• 00886874115497: PATIENT SIDE CART, RECERTIFIED
• 00886874110898: VISION SIDE SYSTEM
• 00886874110744: SURGEON SIDE CONSOLE, SMART PEDALS
• 00886874110720: PATIENT SIDE CART, 4-ARM