Exo Iris Ultrasound System

GUDID 00850018318068

Exo Iris Ultrasound System is a procedural pack that contains Exo Iris probe, Duo Cable, Wireless charger, wall charger, and ultrasound gel.

Exo Imaging, Inc.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00850018318068
• NIH Device Record Key: 924b1bfd-8027-4351-b317-b514c3baa2b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exo Iris Ultrasound System
• Version Model Number: EI2001
• Company DUNS: 080615046
• Company Name: Exo Imaging, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018318068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222198

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-01
• Device Publish Date: 2023-12-22

Devices Manufactured by Exo Imaging, Inc.

• 00850018318068 - Exo Iris Ultrasound System: 2024-01-01Exo Iris Ultrasound System is a procedural pack that contains Exo Iris probe, Duo Cable, Wireless charger, wall charger, and ultrasound gel.
• 00850018318068 - Exo Iris Ultrasound System: 2024-01-01 Exo Iris Ultrasound System is a procedural pack that contains Exo Iris probe, Duo Cable, Wireless charger, wall charger, and ult
• 00850018318006 - Exo Iris: 2023-12-29 Exo Iris is a hand-held, general-purpose diagnostic imaging system.