Suprapubic Catheter Accessories
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Zhejiang.
- Ningbo Landing Technology Company Co., Ltd. Zhejiang
- Ningbo MPF Manufacturing Co., Ltd. Zhejiang, contract manufacturer
What Is It?
Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
What Is FDA Product Code QGC?
Suprapubic Catheter Accessories is FDA product code QGC, Class 1, 21 CFR 876.5100.
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.
Name
Record