XACT ACE Robot XR-ACE-RBT

GUDID 07290017702018

XACT ACE Robot

XACT ROBOTICS LTD

Robotic surgical arm system

• Primary Device ID: 07290017702018
• NIH Device Record Key: 86689933-41ba-4c45-a4cc-93342f1b664e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XACT ACE Robot
• Version Model Number: B
• Catalog Number: XR-ACE-RBT
• Company DUNS: 600405981
• Company Name: XACT ROBOTICS LTD
• 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: true
• 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: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com
• Phone: +18883179228
• Email: customerservice@xactrobotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017702018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221116

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-01-19

Devices Manufactured by XACT ROBOTICS LTD

• 17290017702091 - XACT Robotics: Robot Drape: 2024-07-25 Robot Medical Drape
• 07290017702100 - Respiration Sensor Drape: 2024-07-25 Respiration Sensor Drape
• 17290017702152 - XACT Robotics: Disposable Kit: 2024-07-25 XACT Robotics: Disposable Kit
• 07290017702247 - Aiming Plate Drape: 2024-07-25 Aiming Plate Drape
• 07290017702308 - 1.5mm Ablation Instrument Insertion Kit: 2023-08-11 1.5mm Ablation Instrument Insertion Kit
• 07290017702018 - XACT ACE Robot: 2023-06-19XACT ACE Robot
• 07290017702018 - XACT ACE Robot: 2023-06-19 XACT ACE Robot
• 07290017702254 - ACE: 2022-07-28 XACT ACE Robotic System