FDA-Device2018-05-09Class II
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
DeRoyal Industries Inc
Hazard
Non-sterile product was packaged inside a case that was labeled as sterile.
Sold states
Honduras, Belgium, and The Netherlands
Affected count
1800 pencils
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2018Don't want to check this manually?
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