daVinci X

GUDID 00886874115404

PATIENT SIDE CART, 4-ARM

INTUITIVE SURGICAL, INC.

Robotic surgical system

• Primary Device ID: 00886874115404
• NIH Device Record Key: 41244827-867b-48a2-b743-8c13f8b2704b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: daVinci X
• Version Model Number: 380620
• 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	00886874115404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171294

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: 43
• Public Version Date: 2020-03-20
• Device Publish Date: 2017-06-06

Devices Manufactured by INTUITIVE SURGICAL, INC.

• 00886874123447 - EndoWrist SP: 2024-12-17 FENESTRATED BIPOLAR FORCEPS
• 00886874123454 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS
• 00886874123461 - EndoWrist SP: 2024-12-17 MARYLAND BIPOLAR FORCEPS
• 00886874123478 - EndoWrist SP: 2024-12-17 NEEDLE DRIVER
• 00886874123843 - EndoWrist SP: 2024-12-17 CADIERE FORCEPS
• 00886874124031 - EndoWrist SP: 2024-12-17 ROUND TOOTH RETRACTOR ER
• 00886874124048 - EndoWrist SP: 2024-12-17 MONOPOLAR CURVED SCISSORS ER
• 00886874124055 - EndoWrist SP: 2024-12-17 FORCE BIPOLAR ER