Devices

Electrode , depth

Model / Serial
Lot number 208140447 Batch Number 0060002; Lot Number 208140458 Batch Number 0061723; LotNumber208140487R Batch Number 0067938.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) in the states of: CO, FL, LA, NJ, OH, WA, and WI; and internationally to: Finland.
Product Description
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . || Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. || Box Label: 2 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-2KDINX . || Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-2X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX.
Manufacturer
Ad-Tech Medical Instrument Corporation
1 Event
- Recall of Electrode , depth

Manufacturer

Ad-Tech Medical Instrument Corporation

Manufacturer Address
Ad-Tech Medical Instrument Corporation, 1901 William St, Racine WI 53404-1876
Manufacturer Parent Company (2017)
Ad-Tech Medical Instrument Corporation
Source
USFDA

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