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The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run.
Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution
- 00816270020088 ()
20012431
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Can be used in place of Cardiac Science™ electrodes part # 9131-001.
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and
not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to
be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and
deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over
8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8
hours)
HEART SYNC INC
T100-CS
In Commercial Distribution
- 00868866000004 ()
- 10868866000001 ()
T100-CS
- Electrode conductive skin pad, single-use
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter.
Indications for Use:
The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of:
• Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D;
• Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and
• Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;
in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution
- 04049471095074 ()
- Weight: 295 Kilogram
- x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m
- Ophthalmic excimer laser system
The Model 2740C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-018-001
In Commercial Distribution
- 00855728005994 ()
2740C
- Implantable sleep apnoea treatment system, respiration-sensing
The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck.
REVISION OPTICS, INC.
607-0002
In Commercial Distribution
- 10850394006051 ()
607-0002
- Ophthalmic surgical instrument handle, manual
The Model 2740S&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-026-001
In Commercial Distribution
- 00810098650311 ()
2740S&C
- Implantable sleep apnoea treatment system, respiration-sensing
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
BAXTER HEALTHCARE CORPORATION
1514243
In Commercial Distribution
- 35413765583415 ()
- 05413765583414 ()
- 55413765583419 ()
1514243
- Open-surgery adhesive/sealant applicator, dual-channel
Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation.
BAXTER INTERNATIONAL INC.
0600021
In Commercial Distribution
- 00085412087788 ()
- 50085412087783 ()
0600021
- Open-surgery adhesive/sealant applicator, dual-channel
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Dual Coil
In Commercial Distribution
- 00888912011488 ()
01-203-0001
- Patient-worn bone growth electromagnetic stimulator
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 3
In Commercial Distribution
- 00888912161763 ()
01-211-0003
- Patient-worn bone growth electromagnetic stimulator