Device product

6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA

Z-1910-2021

April 29, 2021

Class II

Product summary

Firm: Exact Medical Manufacturing, Inc.
Event: Event 87958
Status: Terminated
Classification: Class II
Quantity: 7920 units
Official record key: device-enforcement:Z-1910-2021

Official wording

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

Code information: Lot Numbers: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071

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