Aesculap
PLESTER Scraper, 60 °, angled, 6 1/4", (160 mm), width: 2 mm, non-sterile, reusable
Scrapper, Skin Specimen
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hebei and Shanghai.
- Foshan Ruiyi Electronic Technology Co., Ltd. Guangdong
- Miley Technology (Hebei) Co., Ltd. Hebei, contract manufacturer
- Shanghai Reach Medical Instrument Co., Ltd. Shanghai
- Shenzhen Trendz Technology Co., Ltd. Guangdong
What Is FDA Product Code LXK?
Scrapper, Skin Specimen is FDA product code LXK, Class 1, 21 CFR 878.4800.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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