HYGITECH
HYGITECH · Model HY-055 · UDI-DI 03615140000321
10
510(k) clearances
438
Adverse events
5
Recalls
402
Facilities
Description
Convenient - Easy to tear off and apply Its delicate adhesive layer makes Hygifilm easily removable without damaging your equipment or walls. - Supplied as a roll of 10cm x 14,5xm pre-perforated adhesive sheets, presented in a dispenser box. In order to prevent cross-contamination, all surfaces that are likely to be touched by the medical team during the surgery should be covered. Hygifilm helps fight cross-contamination by isolating all surfaces that are impossible or difficult to autoclave: dental light handles, computer mice, computer control panel, keyboards and telephones...
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-05 | SpineFrontier, Inc. | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
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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.