FDA-Device2016-12-28Class II
Ultroid Sterile Disposable Probes sold individually
Ultroid Technologies, Inc.
Hazard
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Sold states
AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam
Affected count
7,784
Manufactured in
3140 W Kennedy Blvd Suite 103, N/A, Tampa, FL, United States
Products
Ultroid Sterile Disposable Probes sold individually
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0785-2017Don't want to check this manually?
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