Address:Tunbytorpsgatan 31,Vasteras Vastmanland,SE
Device Description : Operio Mobile is a clean air zone unit, with an integrateddetachable instrument Operio Mobile is a clean air zone unit, with an integrateddetachable instrument tray, to be used in the operatingzone, which produces a directed, non-turbulent ultracleanair flow to the surgical site during ophthalmic,orthopedic and neuro surgery and to the sterileinstruments used during surgery.
Device Class : 2
Duns Number: 427895198
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Sterile shield LAF 02 is a single-use sterile consumable to be used together The Sterile shield LAF 02 is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02 has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02 is attached on the Operio device on the outlet of the HEPA filtered ultra clean air.Instructions on how to use and mount the sterile shield LAF 02 is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.
Device Class :
Duns Number: 427895198
Premarket Exempt : Yes
Prescription Use : No
Device Description : SteriStay is a mobile instrument table intended for use in the operating environ SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms.
Device Class : 2
Duns Number: 427895198
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Sterile shield LAF 02-D is a single-use sterile consumable to be used togeth The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02-D has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02-D is attached on the Operio device on the outlet of the HEPA filtered ultra clean air.Instructions on how to use and mount the sterile shield LAF 02-D is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.
Device Class :
Duns Number: 427895198
Premarket Exempt : Yes
Prescription Use : No
Device Description : Surgical Drape for use with the SurgiCube air flow units are intended to be used Surgical Drape for use with the SurgiCube air flow units are intended to be used as a sterile protective barrier between the outcoming filtered air of the air flow unit and the environmental air, protecting the clean air area from potential (non-) viable particles.
Device Class :
Duns Number: 427895198
Premarket Exempt : Yes
Prescription Use : No