FDA device listing

EAR LOOP

FDA device listing 1310660918 · BLACK & BLACK SURGICAL, INC.

Key facts

Proprietary names EAR LOOP
Owner/operator BLACK & BLACK SURGICAL, INC.
Owner/operator number 9097380
Product codes JYG
Device names JYG - Curette, Ear
Device class Class I
Classification regulations (21 CFR) 874.4420
Review panels Ear, Nose, & Throat
Registered establishments BLACK & BLACK SURGICAL, INC.
Establishment registrations 3006142527
FEI numbers 3006142527
Establishment operations 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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