FDA-Device2013-06-12Class II
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Gyrus Acmi, Incorporated
Hazard
lack of sterility assurance
Sold states
Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
Affected count
100 boxes of 6 units
Manufactured in
136 Turnpike Road, N/A, Southborough, MA, United States
Products
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1439-2013Don't want to check this manually?
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