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The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
Pramand LLC
CS-2055
In Commercial Distribution
- 00860010683712 ()
- 00860010683705 ()
- Total Volume: 5 Milliliter
CS-2055
- Dura mater sealant
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® 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 Dual Axis® Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is a 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, violet 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 Dual Axis
In Commercial Distribution
- B22219 ()
- Orthokeratology contact lens
The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw.
T-Handle 5mm
Socket M9
Guide Pin Rescue
Drill Bit Holder
Drill / Torx Guide
Allen Key 2.5 mm
Integrum AB
2533
In Commercial Distribution
- 07340152102027 ()
- Internal-external leg prosthesis osseointegration bar
ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, non-flammable gas. The boiling point is -63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum), carbon tetrafluoride 100 ppm (maximum), and hydrogen fluoride 0.3 ppm (maximum).
ESCALON MEDICAL CORP.
20 g Cylinder
In Commercial Distribution
- 10860113000116 ()
- 00860113000119 ()
- 20860113000113 ()
TR9088
- Vitreous/aqueous humour replacement medium, intraoperative
Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.
ENDOMAGNETICS LTD
MTVC10001
In Commercial Distribution
- 15060391210244 ()
- Magnetic nanoparticle tracer
Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance.
Kit content:
Part Description
ASM000355 PATIENT MEMBRANE PACKING ASSY
SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET
SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-BB Neuro V2 Kit 3T for USA
In Commercial Distribution
- 07290015461511 ()
SET000960-BB
- Therapeutic oncological/gynaecological ultrasound system
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-7560-01
In Commercial Distribution
- 30850009370250 ()
- 10850009370256 ()
03-7560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-3560-01
In Commercial Distribution
- 10850009370195 ()
- 30850009370199 ()
03-3560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding the Patient Transmit Coil over the location of the implanted Rechargeable Neuroregulator during charging.
Reshape Lifesciences Inc.
1660
Not in Commercial Distribution
- 00857334004217 ()
- Width: 2 Inch
- Length: 58 Inch
1660
- Electrical cable/lead holder
The TriVascular® Ovation Prime® Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
The TriVascular Ovation Prime Abdominal Stent Graft System includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
Trivascular, Inc.
Iliac Limb
In Commercial Distribution
- M701TVIL1418120E1 ()
- Catheter Gauge: 14 French
- Length: 120 Millimeter
- Outer Diameter: 18 Millimeter
- Outer Diameter: 14 Millimeter
TV-IL1418120-E
- Abdominal aorta endovascular stent-graft