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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
TUXEDO INTRAORAL SENSOR
In Commercial Distribution
- 00860008321336 ()
6101AR Size 2
- Dental digital imaging sensor, intraoral
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
TUXEDO INTRAORAL SENSOR
In Commercial Distribution
- 00860008321329 ()
6100AR Size 1
- Dental digital imaging sensor, intraoral
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
TUXEDO INTRAORAL SENSOR
In Commercial Distribution
- 00860008321312 ()
6101A Size 2
- Dental digital imaging sensor, intraoral
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
TUXEDO INTRAORAL SENSOR
In Commercial Distribution
- 00860008321305 ()
6100A Size 1
- Dental digital imaging sensor, intraoral
VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display.
The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data.
The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
VIVALNK, INC.
VV350
In Commercial Distribution
- 00860008259233 ()
- Electrocardiography telemetric monitoring system
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
A50
In Commercial Distribution
- 00860008259226 ()
- Dressing-fixation skin adhesive tape, non-silicone
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
B08
In Commercial Distribution
- 00860008259219 ()
- Dressing-fixation skin adhesive tape, non-silicone
Hydrogel Adhesive is a disposable adhesive patch containing small, thin layers of soft adhesives used for the adherence of specific sensor.
VIVALNK, INC.
A35
In Commercial Distribution
- 00860008259202 ()
- Dressing-fixation skin adhesive tape, non-silicone
Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological tablet produced using cellulose, and enzymes from Geobacillus stearothermophilus ATCC® 7953
For use in Monitoring Steam Sterilization Processes at 121C, 30 minutes (Gravity), 132C , 4 minutes (Pre-Vacuum) and 135C, 3 minutes (Pre-Vacuum)
True Indicating LLC
ISCS-05
In Commercial Distribution
- 00860008246707 ()
ISCS-05
- Chemical/physical sterilization process indicator
The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination.
The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens.
ASP Health Inc.
REV P
In Commercial Distribution
- 00860008222404 ()
PI-0076558
- Microscope slide stainer IVD