FDA-Device2021-08-25Class II
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Ortho8, Inc.
Hazard
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Sold states
US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.
Affected count
N/A
Manufactured in
2217 Plaza Dr, N/A, Rocklin, CA, United States
Products
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2324-2021Don't want to check this manually?
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