uREzpocus

GUDID 00860008461209

Ultrasonic pulsed doppler imaging system - Convex HD array

Norland at Swissray

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00860008461209
• NIH Device Record Key: 2690b03e-9280-4a29-86c9-b0056b6ac2e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uREzpocus
• Version Model Number: uREzpocus C-EMS
• Company DUNS: 110329096
• Company Name: Norland at Swissray
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008461209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210432

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: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [uREzpocus]

• 00866955000492: Linear probe.
• 00866955000485: Convex probe.
• 00860008461223: Ultrasonic pulsed doppler imaging system - MicroConvex array
• 00860008461216: Ultrasonic pulsed doppler imaging system - uREzpocus H
• 00860008461209: Ultrasonic pulsed doppler imaging system - Convex HD array