FDA device listing

BEAR

FDA device listing 1157410314 · BEAR-ENT, LLC

Key facts

Proprietary names BEAR
Owner/operator BEAR-ENT, LLC
Owner/operator number 10084364
Product codes HNF
Device names HNF - Scissors, Ophthalmic
Device class Class I
Classification regulations (21 CFR) 886.4350
Review panels Ophthalmic
Registered establishments BEAR-ENT, LLC
Establishment registrations 3021680161
FEI numbers 3021680161
Establishment operations Complaint File Establishment, Manufacturer, Repackager/Relabeler, Specification Developer
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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