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SurgiCube drape
Toul Meditech AB · Model SCDR180 · UDI-DI 07350101640098
7
510(k) clearances
19
Adverse events
1
Recalls
46
Facilities
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-03 | Alcon Research, Ltd. | The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. |
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Get your free API keyRead the docsData 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.