Device product

6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N

Z-1912-2021

April 29, 2021

Class II

Product summary

Firm: Exact Medical Manufacturing, Inc.
Event: Event 87958
Status: Terminated
Classification: Class II
Quantity: 9680 units
Official record key: device-enforcement:Z-1912-2021

Official wording

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

Code information: Lot Numbers: 1912E127 2003E794 2002E132 2003E801 2004E024 2004E514 2009E127 2008E357 2009E467 2009E250 2011E108 2012E100 2012E104

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