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Devices
Device Recall Fixed Tip Electrosurgical Electrode.
Model / Serial
Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
Product Description
AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Manufacturer
Encision, Inc.
1 Event
Recall of Device Recall Fixed Tip Electrosurgical Electrode.
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Manufacturer
Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
Source
USFDA
Language
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