FDA-Device2013-08-21Class II
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Atrium Medical Corporation
Hazard
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
Sold states
USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.
Affected count
15,630 units
Manufactured in
5 Wentworth Dr, Hudson, NH, United States
Products
C-QUR TacShield Mesh (All sizes and shapes). Intended for use in soft tissue deficiencies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1939-2013Don't want to check this manually?
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