daVinci Si

GUDID 00886874110881

FLUORESCENCE IMAGING CAMERA HEAD AND CABLE KIT

INTUITIVE SURGICAL, INC.

Rigid optical laparoscope

• Primary Device ID: 00886874110881
• NIH Device Record Key: 27ccf562-295b-450f-9064-842b3a74cafe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: daVinci Si
• Version Model Number: 381103
• 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	00886874110881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101077

FDA Product Code

• IZI: System, x-ray, angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-02
• Device Publish Date: 2016-07-08

On-Brand Devices [daVinci Si]

• 00886874110881: FLUORESCENCE IMAGING CAMERA HEAD AND CABLE KIT
• 00886874110874: VISION SIDE SYSTEM
• 00886874110799: VISION SIDE SYSTEM, RECERTIFIED
• 00886874110782: SURGEON SIDE CONSOLE, RECERTIFIED
• 00886874110775: PATIENT SIDE CART, RECERTIFIED
• 00886874110751: PATIENT SIDE CART, RECERTIFIED
• 00886874110737: PATIENT SIDE CART, 4-ARM, RECERTIFIED
• 00886874110713: PATIENT SIDE CART, 3-ARM
• 00886874110690: PATIENT SIDE CART, 4-ARM
• 00886874110683: SURGEON SIDE CONSOLE