Xray2Go

GUDID 00858475006009

Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

DENTERPRISE INTERNATIONAL, INC.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 00858475006009
• NIH Device Record Key: c50003d3-a0dc-464a-a8f0-8a170bb489c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xray2Go
• Version Model Number: Xray2Go 3mA
• 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: 800-323-2690
• Email: info@denterpriseintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858475006009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141497

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2018-07-06Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
• 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.