FDA device listing

Tonsil Needle

FDA device listing 1388184858 · Hayden Medical

Key facts

Proprietary names Tonsil Needle
Owner/operator Hayden Medical
Owner/operator number 10026720
Product codes KBR
Device names KBR - Needle, Tonsil Suturing
Device class Class I
Classification regulations (21 CFR) 874.4420
Review panels Ear, Nose, & Throat
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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