FDA device listing

Face Shield,Goggle

FDA device listing 1072691980 · Obbomed Group LLC

Key facts

Proprietary names Face Shield,Goggle
Owner/operator Obbomed Group LLC
Owner/operator number 10048805
Product codes HOY
Device names HOY - Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device class Class I
Classification regulations (21 CFR) 886.4750
Review panels Ophthalmic
Registered establishments OBBOMED GROUP LLC
Establishment registrations 3011447447
FEI numbers 3011447447
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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