FDA device listing

Collector, Ostomy

FDA device listing 1276663870 · Mainline Medical Dental Supply

Key facts

Owner/operator Mainline Medical Dental Supply
Owner/operator number 10052656
Premarket submissions K791525
Product codes EXB
Device names EXB - Collector, Ostomy
Device class Class I
Classification regulations (21 CFR) 876.5900
Review panels Gastroenterology & Urology
Registered establishments MAINLINE MEDICAL DENTAL SUPPLY
Establishment registrations 3012421607
FEI numbers 3012421607
Establishment operations Foreign Exporter
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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