FDA device listing

barrier sleeves and films

FDA device listing 1544893908 · Young Innovations Inc

Key facts

Proprietary names barrier sleeves and films
Owner/operator Young Innovations Inc
Owner/operator number 10028124
Product codes EGZ
Device names EGZ - Holder, Film, X-Ray
Device class Class I
Classification regulations (21 CFR) 872.1905
Review panels Dental
Registered establishments YOUNG INNOVATIONS INC.
Establishment registrations 2024980
FEI numbers 3008875470
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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