Search

48 matching records for System M STEP.

NDC#

DailyMed#

GMDN Terms#

Diskectomy system, percutaneous, automatic

49 GUDID devices

An automated system intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. This system is used to resect and aspirate the nucleus pulposus in one step, eliminating the need for repeated insertion of the nucleo...

Surgical power tool system control unit, line-powered

384 GUDID devices

A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions...

Electrocardiography telemetric monitoring system

258 GUDID devices

An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter w...

Microbial identification mass spectrometry system IVD

28 GUDID devices

An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/prep...

Pulse oximetry telemetric monitoring system

26 GUDID devices

An assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable tra...

Electroencephalography telemetric monitoring system

11 GUDID devices

An assembly of devices designed to continuously measure and wirelessly transmit electroencephalographic (EEG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitte...

Laboratory container robotic transfer system IVD, automated

5 GUDID devices

An assembly of electrically-powered robotic devices, or stand-alone device, intended to be used for the automated transfer of assay containers (e.g., test tubes, microplates) between processing stations, as part of a pre-set algorithm or assay procedure. Th...

Electromyography telemetric monitoring system

3 GUDID devices

An assembly of devices designed to continuously measure and wirelessly transmit electromyographic (EMG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with...

Laboratory container robotic transfer system IVD, semi-automated

3 GUDID devices

An assembly of electrically-powered robotic devices, or stand-alone device, intended to be used for the semi-automated transfer of assay containers (e.g., test tubes, microplates) between processing stations, as part of a pre-set algorithm or assay procedur...

Microbial culture plate imaging/analysis system IVD

3 GUDID devices

An electrically-powered device intended to be used for the imaging and assessment of pre-inoculated, pre-incubated microbial culture plates. It typically consists of a sample handling/preparation unit, digital camera, optical reader, transfer unit and dedic...

Surgical power tool system handpiece, sawing, line-powered

193 GUDID devices

A hand-held, line-powered device (which may in addition include a rechargeable battery) that consists of a motorized saw handpiece intended to provide sagittal, oscillating, or reciprocating movement for attachable serrated blades designed to cut through ha...

Computed radiography digital imaging scanner

157 GUDID devices

A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing...

Chemiluminescent immunoassay analyser IVD, automated

54 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunolog...

Dental computed radiography digital imaging scanner

54 GUDID devices

A device/device assembly designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy p...

Computed radiography digital imaging scanner

53 GUDID devices

A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing...

Fluorescent immunoassay analyser IVD, laboratory, automated

46 GUDID devices

A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers tha...

Multiplex analyser IVD, laboratory, semi-automated

30 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which in...

Flow cytometry analyser IVD, automated

20 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electric...

Stair-climbing exerciser, non-powered

20 GUDID devices

An exercise apparatus designed to simulate the motion of climbing stairs primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period (aerobics); it also promotes lower-body muscle strength. It ...

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

17 GUDID devices

A stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers tha...

Multi-modality clinical specimen analysis system IVD

14 GUDID devices

An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of ...

Flow cytometry analyser IVD, semi-automated

13 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electric...

Immunohaematology/blood bank analyser IVD, automated

13 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening/identification/titration, direct antiglobulin tests and/or crossmatching of clinical specimens (from donor and pat...

Microplate/tube/assay card incubator IVD

13 GUDID devices

An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. I...

Dental computed radiography digital imaging scanner

11 GUDID devices

A device/device assembly designed to be used with an analogue dental x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy p...

Enzyme immunoassay (EIA) analyser IVD, automated

11 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-b...

Radioimmunoassay analyser IVD, semi-automated

11 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a radiometric...

Electrophoresis analyser IVD, automated

8 GUDID devices

An electrically-powered laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate o...

Microarray analyser IVD, semi-automated

8 GUDID devices

A mains electricity (AC-powered) laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or ...

Lower-limb mechanical weight exerciser

7 GUDID devices

A mechanical exercise apparatus intended primarily to strengthen the major muscles of the lower body (e.g., quadriceps, hamstrings, calves, hip adductors, gluteus maximus) through a repetitive squatting, stepping, lunging, extending, curling, or pushing mot...