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The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, and primary analysis on the NextSeq™ 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay.
The LRM software (SW) includes the UDI information in the User Interface.
ILLUMINA, INC.
20063024
In Commercial Distribution
- 00816270020415 ()
20063024
- Nucleic acid sequencing reagent kit IVD
The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and primary analysis on the MiSeq™Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The LRM software (SW) includes the UDI information in the User Interface.
ILLUMINA, INC.
20063022
In Commercial Distribution
- 00816270020392 ()
20063022
- Nucleic acid sequencing reagent kit IVD
It is a Wi-Fi camera with type C connection that allows the digitization of images taken on Tablets, smartphones and PCs using dedicated Apps and Software. It is compatible with most optical devices such as microscopes, endoscopes and fiberoptic endoscopes, lenses with C-mount type attachment in addition to the appropriate Couplers or adapters supplied.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-309
Not in Commercial Distribution
- B1621111 ()
- Otoscope, direct
Standard Imaging Lucy 3D QA Phantom is designed to perform comprehensive quality assurance tests for an entire stereotactic radiosurgery/SRT procedure. The phantom allows verification of treatment planning software calculations for volume measurements, distance measurements, image fusion and image transfer. Dosimetry verification is accomplished via components that accommodate ion chambers, film, MOSFETs, TLDs and polymer gels.
STANDARD IMAGING INC.
91210
In Commercial Distribution
- 00850019946505 ()
91210
- Multi-modality therapeutic radiation phantom, test object
TERA HARZ GUARD is designed to assist the dentist in prescribing a device to prevent a patient from grinding their teeth. The production of final devices in the dental clinic requires a computer-aided design and manufacturing (CAD/CAM) system, which includes the following: intraoral scanner, design software, additive 3D printer (DLP/SLA/LCD), and post curing unit.
Graphy Inc.
TE-151
In Commercial Distribution
- 08800142100949 ()
- Dental appliance fabrication material, resin
The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, run monitoring, primary and secondary analysis on the NovaSeq™ 6000Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay.
The software (SW) includes the UDI information in the User Interface.
ILLUMINA, INC.
20074609
In Commercial Distribution
- 00816270020743 ()
20074609
- Nucleic acid sequencing reagent kit IVD
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution
- 00850017250079 ()
- Posturography system platform
The Q-Sense CPM Thermal Sensory Analyzer is a QST (Quantitative Sensory Testing) device including advanced software package designed for clinical use and advance research in the field of Pain Management. The CPM Model offers additional capabilities to the Q-Sense device including: Simultaneous operation of two Thermodes, Ramp & Hold method, Computerized Visual Analog Scale (CoVAS).
The Device includes: main unit, two thermodes and accessories.
MEDOC LTD.
Q-Sense CPM
In Commercial Distribution
- 07290103039257 ()
- 07290103039752 ()
MO 00013-CPM
- Thermotester, diagnostic
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
ANGLED
In Commercial Distribution
- 08437018413294 ()
- Length: 259 Millimeter
- Weight: 122 Gram
- Width: 40 Millimeter
- Height: 40 Millimeter
IC-1180
- Intraoperative gamma radiation detection system probe, reusable
GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment.
The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use.
GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
HI-S
In Commercial Distribution
- 08437018413096 ()
- Height: 40 Millimeter
- Length: 255 Millimeter
- Weight: 182 Gram
- Width: 40 Millimeter
IC-1160
- Intraoperative gamma radiation detection system probe, reusable