FDA-Device2014-12-03Class II
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
CooperSurgical, Inc.
Hazard
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
Sold states
Worldwide Distribution - USA (Nationwide) and Internationally to Canada, Portugal, and Hong Kong.
Affected count
595 units
Manufactured in
75 Vista Pl, N/A, Trumbull, CT, United States
Products
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2015Don't want to check this manually?
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