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Sterile Shield

Toul Meditech AB · Model LAF-02-D · UDI-DI 07350101640067

510(k) clearances

Adverse events

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Description

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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.