FDA-Device2014-09-10Class II
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Mentor Texas, LP.
Hazard
The device labeling is stamped with 330cc and the device is actually 380cc device.
Sold states
U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.
Affected count
34 units
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Products
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2014Don't want to check this manually?
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