UltraVision n/a

GUDID B616UVTKL1440

Linear Ultrasonic Transducer

ULTRAVISION CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: B616UVTKL1440
• NIH Device Record Key: 7a9bd77a-fb8c-454b-9ee4-5d329c3cd332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraVision
• Version Model Number: Konica Linear Probe L14-4
• Catalog Number: n/a
• Company DUNS: 080218827
• Company Name: ULTRAVISION CORPORATION
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com
• Phone: 561-626-4055
• Email: hscott@UltraVisionUSA.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B616UVTKL1440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173265

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [UltraVision]

• B616UVXS0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXR0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXP0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXC0: General Purpose Diagnostic Ultrasonic Imaging System
• B616UVTKL1440: Linear Ultrasonic Transducer
• B616UVTKHL1840: Linear Ultrasonic Transducer
• B616UVTKCC520: Curved Ultrasonic Transducer