FDA-Device2016-11-16Class II
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Covidien LLC
Hazard
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Sold states
Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Affected count
118,800
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0365-2017Don't want to check this manually?
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