FDA device listing

BOSS

FDA device listing 2038392289 · BOSS INSTRUMENTS, LTD.

Key facts

Proprietary names BOSS
Owner/operator BOSS INSTRUMENTS, LTD.
Owner/operator number 9005081
Product codes HFB
Device names HFB - Forceps, Biopsy, Gynecological
Device class Class I
Classification regulations (21 CFR) 884.4530
Review panels Obstetrics/Gynecology
Registered establishments BOSS INSTRUMENTS, LTD.
Establishment registrations 1056350
FEI numbers 1000140363
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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