FDA device listing

Aufricht Retractor, Converse Nasal Retractor; Cottle Nasal Speculum; Gruber Ear Speculum; Killian Nasal Speculum;,Vienna…

FDA device listing 1781977514 · Hayden Medical

Key facts

Proprietary names Aufricht Retractor, Converse Nasal Retractor; Cottle Nasal Speculum; Gruber Ear Speculum; Killian Nasal Speculum;,Vienna Nasal Speculum
Owner/operator Hayden Medical
Owner/operator number 10026720
Product codes EPY
Device names EPY - Speculum, Ent
Device class Class I
Classification regulations (21 CFR) 878.1800
Review panels General & Plastic Surgery
Registered establishments Hayden Medical Inc
Establishment registrations 3007137643
FEI numbers 3007137643
Establishment operations Repackager/Relabeler
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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