Quick Ray HD No Logo #1

GUDID 00858475006047

Indications For Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

DENTERPRISE INTERNATIONAL, INC.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: 00858475006047
• NIH Device Record Key: 30c623e5-f8fb-4d9b-b3ca-2aa05461fad1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quick Ray HD No Logo #1
• Version Model Number: S11684-12 Hama Size #1
• Company DUNS: 024913248
• Company Name: DENTERPRISE INTERNATIONAL, INC.
• 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: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com
• Phone: 8003232690
• Email: info@denterpriseintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858475006047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151926

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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: 2017-02-01

Devices Manufactured by DENTERPRISE INTERNATIONAL, INC.

• 00858475006337 - Smil-O-Ray: 2024-01-15 Portable X-ray System
• 00858475006269 - QuickRay DX Size 1: 2023-08-02
• 00858475006276 - QuickRay DX Size 2: 2023-08-02
• 00858475006115 - iCam: 2022-02-11 Intraoral Camera
• 00858475006177 - InstaRay: 2019-08-01
• 00858475006184 - InstaRay: 2019-08-01 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
• 00858475006009 - Xray2Go: 2018-07-06 Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental tec
• 00858475006016 - QuickRay HD #2: 2018-07-06 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.