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The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.
The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
Integrum AB
2539
In Commercial Distribution
- 07340152101693 ()
- Internal-external leg prosthesis osseointegration bar
The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.
The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
Integrum AB
2538
In Commercial Distribution
- 07340152101686 ()
- Internal-external leg prosthesis osseointegration bar
The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.
The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
Integrum AB
2537
In Commercial Distribution
- 07340152101679 ()
- Internal-external leg prosthesis osseointegration bar
The fixture removal Trephine is a single use instrument used as a cutting tool that drills (cuts) into the bone around and along the Fixture to enable extraction of the Fixture.
The Guide Sleeves are single use instruments. They are used together with the set of guide pins to centre the Trephine around the Fixture when the trephine cuts along the Fixture in the bone.
Integrum AB
2536
In Commercial Distribution
- 07340152101662 ()
- Internal-external leg prosthesis osseointegration bar
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution
- 15420045512474 ()
ASY-15431
- Stationary mammographic x-ray system, digital
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228034094 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused
by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting
that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 5.0
In Commercial Distribution
- 20862478000463 ()
- 00862478000469 ()
- 10862478000466 ()
- 5F
- Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused
by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting
that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.5
In Commercial Distribution
- 20862478000456 ()
- 00862478000452 ()
- 10862478000459 ()
- 5F
- Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused
by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting
that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 3.5
In Commercial Distribution
- 20862478000449 ()
- 00862478000445 ()
- 10862478000442 ()
- 5F
- Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused
by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting
that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.0
In Commercial Distribution
- 20862478000432 ()
- 00862478000438 ()
- 10862478000435 ()
- 5F
- Supersaturated oxygen therapy system catheter