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CHARGING DOCK CD9000 SCS DBS
MEDTRONIC, INC.
CD9000
In Commercial Distribution
- 00763000922399 ()
- Secondary battery
Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”.
The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.
Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon CRT 100
In Commercial Distribution
- B22218 ()
- Orthokeratology contact lens
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 Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
GAMBRO INDUSTRIES
114093
In Commercial Distribution
- 07332414111038 ()
- 37332414111039 ()
114093
- Apheresis system filter, whole blood
TRANSCYTE® is a human fibroblast-derived temporary skin substitute
consisting of a polymer membrane and donated neonatal human
fibroblast cells cultured under aseptic conditions in vitro on a nylon
mesh. Prior to cell growth, this nylon mesh is coated with porcine
dermal collagen and bonded to a polymer membrane (silicone). This
membrane provides a transparent synthetic epidermis when applied.
As fibroblasts proliferate within the nylon mesh, they secrete human
dermal collagen, matrix proteins and growth factors. Following freezing,
no cellular metabolic activity remains; however, the tissue matrix and
bound growth factors are left intact. The human fibroblast-derived
temporary skin substitute provides a temporary protective barrier.
TRANSCYTE is transparent and allows direct visual monitoring of the
wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution
- 00618474000046 ()
- Skin regeneration template, human-/animal-derived
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)
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
143C
Not in Commercial Distribution
- 00745129232382 ()
- Pressure,15-20 mmHg
143CB17
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
143C
Not in Commercial Distribution
- 00745129232344 ()
- Pressure,15-20 mmHg
143CA17
- Compression/pressure sock/stocking, single-use
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 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)