FDA-Device2017-02-08Class II
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Medtronic Advanced Energy, LLC
Hazard
Product sterility compromised due to breach of sterile barrier
Sold states
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Affected count
10 units
Manufactured in
180 International Dr, N/A, Portsmouth, NH, United States
Products
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1126-2017Don't want to check this manually?
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