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Devices
ARTAS System Disposable kit
Model / Serial
Model number FP-45616 and FP45173
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 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 and Non-sterile Disposable Clinical Kit FP -23267): || and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). || 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 ARTAS 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
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한국어