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Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
ORGANOGENESIS INC.
1
In Commercial Distribution
- 00618474000015 ()
- Skin regeneration template, human-/animal-derived
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution
- 05060462240043 ()
- Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0003
In Commercial Distribution
- 05060462240005 ()
- Liver donor-organ preservation/transport system
The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue.
The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT™ (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection.
QIAGEN GmbH
1
In Commercial Distribution
- 04053228034834 ()
874921
- Gastrointestinal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer.
The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations.
FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228034223 ()
873121
- PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)
The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which
are guided through the aperture in the treatment objective .
The optical system focuses the laser beam into the corneal tissue.
The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty
- In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting
- Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
Additionally under class III:
The VisuMax Femtosecond Laser is indicated for use in small incision
lenticule extraction (SMILE) for the reduction or elimination of
myopia with or without astigmatism
• for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters,
• for cylinder from -0.75 diopters through -3.00 diopters,
• when refraction spherical equivalent is no greater in magnitude than 10.00 diopters,
in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VisuMax
In Commercial Distribution
- 04049471095036 ()
- Weight (basic unit) 470 kg
- Weight (PSS): 250 kg
- Weight (platform): 150 kg
- L x W: 4.00 m x 3.70 m
- Femtosecond ophthalmic solid-state laser system
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
850052003739
Not in Commercial Distribution
- 00850052003739 ()
K4120361
- Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution
- 10810098650295 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
The intended purpose is for certified surgeons, to conduct the surgical procedure for Abutment Extraction, facilitate removal of Abutment and Abutment Screw within an OPRA™ Implant System in a patient. Consist of instruments:
Clamp head
Clamp head Pusher
Clamp head Screw
Pressure Peg Hex
T-Handle 5 mm
Spanner 14 mm
Spanner 12 mm
Spanner 10 mm
Integrum AB
2531
In Commercial Distribution
- 07340152101976 ()
- Internal-external leg prosthesis osseointegration bar
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML).
INVIVOSCRIBE, INC.
00810022732571
In Commercial Distribution
- 00810022732571 ()
K4120361
- Acute myeloid leukaemia (AML) genetic mutation IVD, kit, nucleic acid technique (NAT)