FDA device listing

Retractor - DeRoyal

FDA device listing 1432279047 · DEROYAL INDUSTRIES, INC.

Key facts

Proprietary names Retractor - DeRoyal
Owner/operator DEROYAL INDUSTRIES, INC.
Owner/operator number 1044833
Product codes GAD
Device names GAD - Retractor
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments DeRoyal Industries, Inc., DEROYAL INDUSTRIES, INC.
Establishment registrations 1043214, 1054241, 1055236, 2320762
FEI numbers 1043214, 1000112877, 1000112968, 3003040625
Establishment operations Complaint File Establishment, Contract Sterilizer, 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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