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Manufacturers
Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
Source
USFDA
2 Events
Recall of Device Recall Disposable AEM Cord
Recall of Device Recall Fixed Tip Electrosurgical Electrode.
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2 devices in the database
Device Recall Disposable AEM Cord
Model / Serial
REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
Product Description
Encision ES4107 Disposable AEM Cord, Sterile.
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.
2 manufacturers with a similar name
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Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
Source
USFDA
Encision, Inc.
Manufacturer Address
Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
Manufacturer Parent Company (2017)
Encision, Inc.
Source
USFDA
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