Stryker Fecal Management System
Catalogue number 700-128, listed by Sage Products LLC, United States, under Bag, Stomal. 7 manufacturers in China are registered for this product code.
Bag, Stomal
Who Makes This Device Type in China?
7 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Jiangsu and Shandong. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Nanjing Anjian Medical Device Co., Ltd. Jiangsu, contract manufacturer
- Pinghu Sama Medical Packing Co., Ltd. Zhejiang, contract manufacturer
- Shandong Kangli Medical Equipment Technology Co., Ltd. Shandong
- Tongxiang BAO-Health Medical Instrument Co., Ltd. Zhejiang
- Zhejiang Ailebao Medical Technology Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code GDS?
Bag, Stomal is FDA product code GDS, Class 1, 21 CFR 876.5900.
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.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Material/Component Contamination (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.