Ion

GUDID 00886874116241

Controller

INTUITIVE SURGICAL, INC.

Surgical planning/navigation-enhancement system

• Primary Device ID: 00886874116241
• NIH Device Record Key: a2a4d4ac-260f-4a97-9280-71e5fb26ac01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ion
• Version Model Number: 380707
• 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	00886874116241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182188

FDA Product Code

• EOQ: Bronchoscope (flexible or rigid)

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: 2020-03-02
• Device Publish Date: 2019-03-21

On-Brand Devices [Ion]

• 00886874116241: Controller
• 00886874116234: System Cart
• 10886874116125: Vision Probe
• 00886874116258: Catheter
• 10886874119591: None
• 00886874121184: Vision Probe
• 00886874124796: Catheter