Tuxedo 6101BR Size 2 Replacement

GUDID 00860008321374

This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.

Tuxedo Imaging LLC

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• Primary Device ID: 00860008321374
• NIH Device Record Key: 016cbd44-3af0-4734-9050-a30eb348df52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuxedo
• Version Model Number: TUXEDO INTRAORAL SENSOR
• Catalog Number: 6101BR Size 2 Replacement
• Company DUNS: 118567554
• Company Name: Tuxedo Imaging LLC
• 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: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com
• Phone: 877-278-3799
• Email: service@tuxedoimaging.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008321374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153710

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Tuxedo]

• 00860008321336: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321329: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321312: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321305: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321374: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321367: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321350: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval
• 00860008321343: This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for eval