Device product

Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

Z-1917-2021

April 29, 2021

Class II

Product summary

Firm: Exact Medical Manufacturing, Inc.
Event: Event 87958
Status: Terminated
Classification: Class II
Quantity: 51300 units
Official record key: device-enforcement:Z-1917-2021

Official wording

Reason: No 510k for the product to be used in a natural or surgical opening to the body

Code information: Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404

Distribution pattern: US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

No 510k for the product to be used in a natural or surgical opening to the body