Tuxedo 6101AR Size 2

GUDID 00860008321336

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

Dental digital imaging sensor, intraoral
Primary Device ID00860008321336
NIH Device Record Key612a050f-4272-4d36-9c02-f6711f0c1fd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTuxedo
Version Model NumberTUXEDO INTRAORAL SENSOR
Catalog Number6101AR Size 2
Company DUNS118567554
Company NameTuxedo Imaging LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com
Phone877-278-3799
Emailservice@tuxedoimaging.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008321336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-31
Device Publish Date2022-03-23

On-Brand Devices [Tuxedo]

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

Trademark Results [Tuxedo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TUXEDO
TUXEDO
98604800 not registered Live/Pending
Yves Saint Laurent Parfums
2024-06-17
TUXEDO
TUXEDO
90695661 not registered Live/Pending
National Presto Industries, Inc.
2021-05-07
TUXEDO
TUXEDO
90589776 not registered Live/Pending
Mahler Anna Lena
2021-03-19
TUXEDO
TUXEDO
90296248 not registered Live/Pending
Tuxedo Distributors, LLC
2020-11-03
TUXEDO
TUXEDO
90073088 not registered Live/Pending
JC World Bell Wholesale
2020-07-25
TUXEDO
TUXEDO
87825148 not registered Dead/Abandoned
Kallati International Inc.
2018-03-08
TUXEDO
TUXEDO
86563145 not registered Dead/Abandoned
L'Oreal (UK) Ltd
2015-03-13
TUXEDO
TUXEDO
86291926 not registered Dead/Abandoned
CUROPLANT COMPANY LTD.
2014-05-27
TUXEDO
TUXEDO
86244347 not registered Dead/Abandoned
Beneduce Vineyards LLC
2014-04-07
TUXEDO
TUXEDO
85491030 4697899 Live/Registered
TUX CREATIVE INC. / CRÉATIF TUX INC.
2011-12-08
TUXEDO
TUXEDO
85468428 4296335 Live/Registered
CASE-MATE, INC.
2011-11-09
TUXEDO
TUXEDO
85411170 4832072 Live/Registered
VERDESIAN LIFE SCIENCES U.S., LLC
2011-08-30

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