FDA-Device2018-08-22Class II
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Beekley Corporation
Hazard
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Sold states
Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
Affected count
3,384,024 pieces in total.
Manufactured in
1 Prestige Ln, Bristol, CT, United States
Products
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2830-2018Don't want to check this manually?
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