uREzpocus

GUDID 00866955000485

Convex probe.

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

• Primary Device ID: 00866955000485
• NIH Device Record Key: 1dc55a45-61cd-4e6c-842b-162061034d59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uREzpocus
• Version Model Number: uREzpocus C
• 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	00866955000485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191235

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: 2021-03-23
• Device Publish Date: 2021-03-15

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