Iris

GUDID 00886874117538

User Software

INTUITIVE SURGICAL, INC.

Image segmentation application software

• Primary Device ID: 00886874117538
• NIH Device Record Key: b9b45440-f45a-4815-be48-8ff79a63fa82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iris
• Version Model Number: 610040
• 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: false
• 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	00886874117538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182643

FDA Product Code

• LLZ: System, image processing, radiological

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: 2019-06-13

On-Brand Devices [Iris]

• 00886874117538: User Software
• 00886874117507: Kidney 3D Model