Needle, Gastro-Urology

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Shandong.

Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

What Is FDA Product Code FHR?

Needle, Gastro-Urology is FDA product code FHR, Class 1, 21 CFR 878.4800.

What Does It Take to Sell It in the United States?

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.

Needle, Gastro-Urology

Rigid Needle 21 GA X 0.5″ (0,8 X 13 Mm)

Catalogue number 9012M0, listed by Merz North America, Inc., United States, under Needle, Gastro-Urology. 2 manufacturers in China are registered for this product code.

Needle, Gastro-Urology

Pilling

Catalogue number IPN017636, listed by Teleflex Medical LLC, United States, under Needle, Gastro-Urology. 2 manufacturers in China are registered for this product code.

Needle, Gastro-Urology