FDA-Device2014-02-19Class II
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Custom Medical Specialties, Inc.
Hazard
No endotoxin (LAL) testing to proper level.
Sold states
US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.
Affected count
2,610
Manufactured in
330 East Main Street, N/A, Pine Level, NC, United States
Products
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0974-2014Don't want to check this manually?
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