FDA-Device2020-05-13Class II
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
Stryker Corporation
Hazard
Sterile drapes packaged in an unsealed pouch.
Sold states
US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.
Affected count
21,078 units
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2020Don't want to check this manually?
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