FDA-Device2021-06-30Class II

6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA

Exact Medical Manufacturing, Inc.
Hazard

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

Sold states
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Affected count
17545 units
Manufactured in
4917 William St Ste C, N/A, Lancaster, NY, United States
Products
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1909-2021

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