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Devices
ARTUS system Disposable Kit
Model / Serial
Model number FP-45399
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Product Description
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; || Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 || Rx): || Product Usage: || Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
Manufacturer
Restoration Robotics
1 Event
Recall of ARTUS system Disposable Kit
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Manufacturer
Restoration Robotics
Manufacturer Address
Restoration Robotics, 128 Bayview Drive, San Jose CA 95134
Manufacturer Parent Company (2017)
Restoration Robotics, Inc
Source
USFDA
Language
English
Français
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한국어