FDA-Device2021-08-18Class II
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Stryker Medical Division of Stryker Corporation
Hazard
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Affected count
1 unit
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2021Don't want to check this manually?
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