Elite

GUDID 00866955000461

Elite Bone Densitometer

Norland at Swissray

Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: 00866955000461
• NIH Device Record Key: e5d25272-2851-4f78-a189-7aede3c88d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite
• Version Model Number: Elite
• 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: 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: 920-563-8456
• Email: pat.cunniff@swissray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866955000461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992125

FDA Product Code

• KGI: Densitometer, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-16

Devices Manufactured by Norland at Swissray

• 00860008461209 - uREzpocus: 2022-05-03 Ultrasonic pulsed doppler imaging system - Convex HD array
• 00860008461216 - uREzpocus: 2022-05-03 Ultrasonic pulsed doppler imaging system - uREzpocus H
• 00860008461223 - uREzpocus: 2022-05-03 Ultrasonic pulsed doppler imaging system - MicroConvex array
• 00866955000485 - uREzpocus: 2021-03-23 Convex probe.
• 00866955000492 - uREzpocus: 2021-03-23 Linear probe.
• 00866955000478 - IlluminatusDXA Software: 2020-08-04
• 00866955000409 - XR-600 Basic: 2018-07-06 XR-600 Basic Bone Densitometer
• 00866955000416 - XR-600 Clinical: 2018-07-06 XR-600 Clinical Bone Desitometer