FDA-Device2021-08-18Class II
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
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
3 units
Manufactured in
3800 E Centre Ave, N/A, Portage, MI, United States
Products
IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2021Don't want to check this manually?
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