RevoluX

GUDID 04719892352000

Hand Diagnostic Radiography Imaging System

NANORAY BIOTECH CO., LTD.

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04719892352000
• NIH Device Record Key: 1fee3fee-16ec-46c5-bd2e-0d8c25abe6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoluX
• Version Model Number: NDR705
• Company DUNS: 658696687
• Company Name: NANORAY BIOTECH CO., LTD.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com
• Phone: +88627968909
• Email: sales@nanoraybiotech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719892352000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220271

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2023-11-10
• Device Publish Date: 2023-11-02