FDA device listing

Catheter, Retention

FDA device listing 1659043851 · Suzhou Texnet

Key facts

Proprietary names Catheter, Retention
Owner/operator Suzhou Texnet
Owner/operator number 10057231
Product codes FGD
Device names FGD - Catheter, Retention, Barium Enema With Bag
Device class Class II
Classification regulations (21 CFR) 876.5980
Review panels Gastroenterology & Urology
Registered establishments SUZHOU TEXNET
Establishment registrations 3010339057
FEI numbers 3010339057
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings