FDA-Device2013-02-13Class II
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Custom Healthcare Systems, Inc.
Hazard
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Sold states
USA Nationwide Distribution including the states GA, OH, GA, NC and ME.
Affected count
80 trays
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2013Don't want to check this manually?
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