FDA device listing

Armstrong beveled grommet,Armstrong beveled grommet, ultrasil 60/pk,Collar button vent tube,Donaldson ultrasil…

FDA device listing 1955820332 · MIDWEST STERILIZATION CORP.

Key facts

Proprietary names Armstrong beveled grommet,Armstrong beveled grommet, ultrasil 60/pk,Collar button vent tube,Donaldson ultrasil 1.14mm,Duravent tube ultrasil 1.27mm id,Paparella 1.14mm soft silicone ultrasil 30/pk,Paparella, ultrasil, 1.14mm 6/pk,Paparella, ultrasil, 1.14mm id,Paparella, ultrasil, 1.14mm id 60/pk,Paparella vent tube 1.02mm id ultrasil 30/pk,Paparella vt ultrasil w/o tab,Pap type tube sft sil…
Owner/operator MIDWEST STERILIZATION CORP.
Owner/operator number 1928237
Product codes ETD
Device names ETD - Tube, Tympanostomy
Device class Class II
Classification regulations (21 CFR) 874.3880
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

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