FDA-Device2014-06-18Class II
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
Summit Medical, Inc.
Hazard
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Sold states
Worldwide Distribution -- USA, including CA, and GERMANY.
Affected count
9 boxes
Manufactured in
815 Northwest Pkwy Ste 100, N/A, Eagan, MN, United States
Products
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2014Don't want to check this manually?
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