FDA-Device2015-09-23Class II
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Med Tec Inc
Hazard
The wrist straps used for positioning the patient are too long
Sold states
Worldwide Distribution - US including NE, SC, and KS. Foreign distribution was made to Australia, China, Venezuela, Spain, Turkey, and Hong Kong
Affected count
18 sets
Manufactured in
1401 8th St SE, PO Box 320, Orange City, IA, United States
Products
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2763-2015Don't want to check this manually?
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