Address:2440 SOUTH 179TH ST.,NEW BERLIN,WI,53146,US
Device Description : Siepser shielded fiber optic light probe for identifying debris and fibers in th Siepser shielded fiber optic light probe for identifying debris and fibers in the corneal interface or epithelium. , 20 ga, with Universal connector. Sterile, single-use.
Device Class : 2
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : DCR illuminated fiber optic light probe for transillumination of tissue. 20 ga, DCR illuminated fiber optic light probe for transillumination of tissue. 20 ga, with Universal connector. Sterile, single-use.
Device Class : 2
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulatio Hardten Iris Retractor Fiber optic light probe with a hooked tip for manipulation and retraction of the iris for optimal visualization of anterior vitreous. 20 ga, with Universal connector. Sterile, single-use.
Device Class : 1
Duns Number: 879144426
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : For use during silicone oil procedures, irrigating contact lens enables visualiz For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single -use requiring no clean up.
Device Class : 1
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : For use during silicone oil procedures, irrigating contact lens enables visualiz For use during silicone oil procedures, irrigating contact lens enables visualization of surgical field while ensuring proper irrigation of cornea and orbit. Single use requiring no clean up.
Device Class : 1
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : Convenient kit for the controlled and accurate mixing and dispensing of gases. Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. Sterile, single use.
Device Class : 1
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the p A 4 mm beveled tip infusion cannula used as an aid for infusing fluid into the posterior chamber of the eye, and is particularly designed for use with high-viscosity fluids. The flanged cannula is designed to easily suture into place and is qualified for use at operating pressures of up to 70 psi. Sterile, Single Use
Device Class : 1
Duns Number: 879144426
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Single-use procedure pack for injection and aspiration of silicone oil and other Single-use procedure pack for injection and aspiration of silicone oil and other viscous fluids. Connects to Alcon systems. Pack includes 10cc syringe with pressure-tested tubing and adapters, stainless steel cannula, and Teflon cannula. 0.2 micron filter included to maintain sterile field. Sterile, single-use.
Device Class : 2
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administe ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum).
Device Class :
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes
Device Description : ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is adminis 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).
Device Class :
Duns Number: 879144426
Premarket Exempt : No
Prescription Use : Yes