FDA device listing

Adj, micron ti port ctr 2.00mm - 5.00 mm,Adj. micron ti port ofctr 2.00mm - 5.0mm,Adj. micron ti torp ctr 2.00mm…

FDA device listing 1379097676 · MIDWEST STERILIZATION CORP.

Key facts

Proprietary names Adj, micron ti port ctr 2.00mm - 5.00 mm,Adj. micron ti port ofctr 2.00mm - 5.0mm,Adj. micron ti torp ctr 2.00mm - 10.00mm,Adj. micron ti torp ofctr 2.00mm - 10.00mm,Dornhoffer,Micron all titan mon octr torp 6.50mm,Micron ii 1.5mm ctr porp monolithic all titanium,Micron II 2.5mm ctr porp monolithic all titanium,Micron II 2.5mm ctr torp monolithic all titanium,Micron II 2.5mm octr all titanium…
Owner/operator MIDWEST STERILIZATION CORP.
Owner/operator number 1928237
Product codes ETA, ETB
Device names ETA - Replacement, Ossicular Prosthesis, Total, ETB - Prosthesis, Partial Ossicular Replacement
Device class Class II
Classification regulations (21 CFR) 874.3450, 874.3495
Review panels Ear, Nose, & Throat
Registered establishments MIDWEST STERILIZATION CORP.
Establishment registrations 1928237
FEI numbers 1928237
Establishment operations Contract Sterilizer
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