mi-ultra CX

GUDID 00857356008019

Ultrasound Convex Transducer

TRICE MEDICAL, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00857356008019
• NIH Device Record Key: 051a6cdb-2d50-4133-b158-01f7a14ac73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mi-ultra CX
• Version Model Number: T900-021
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, 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: 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: 6109898080
• Email: customerservice@tricemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857356008019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163443

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2018-09-06
• Device Publish Date: 2018-08-06

Devices Manufactured by TRICE MEDICAL, INC.

• 00857356008026 - mi-eye 2: 2023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN
• 00857356008118 - mi-eye 2: 2023-11-17 TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM
• 00857356008224 - mi-tablet 3: 2023-11-17 mi-tablet 3
• 00857356008231 - mi-eye 3: 2023-11-17 mi-eye 3 needlescope, 95mm
• 00857356008248 - mi-eye 3: 2023-11-17 mi-eye 3 angled scope, 120mm
• 00857356008255 - mi-eye 3: 2023-11-17 mi-eye 3 25 deg scope, 75mm with cannula
• 00857356008262 - mi-eye 3: 2023-11-17 mi-eye 3 scope, 95mm with cannula
• 00857356008279 - mi-eye 3: 2023-11-17 mi-eye 3 25° scope, 75mm with cannula