Clean Ultrasound Probe Cover
Catalogue number N00102, listed by Nanosonics, Inc., United States, under Cover, Biopsy Forceps. 2 manufacturers in China are registered for this product code.
Cover, Biopsy Forceps
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Anhui. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Anqing Kangmingna Packaging Co., Ltd. Anhui, contract manufacturer
- TF NEW Material SCI AND TEC Co., Ltd. Anhui
How Is FFF Classified?
Cover, Biopsy Forceps is FDA product code FFF, Class 1, 21 CFR 876.1075.
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.
What Has Gone Wrong With It?
The FDA has recorded 5 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Process control (3) and Error in labeling (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record