U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Microneedle Roller/Stamp - Product Code PIU
원인
Derma pen initiated a field communication for dermapen after receiving an fda warning letter for distributing a device without fda clearance or approval.
조치
Derma Pen sent a notification letter to its customers on February 5, 2015. The purpose of the notification was to inform customers that the FDA issued a warning letter and the steps Derma Pen was taking to address the FDA' s concerns.
For further questions please call (800) 981-5402.
Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.
제품 설명
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.