FDA device listing

SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

FDA device listing 1894602050 · DARLEYS SURGICAL CO.

Key facts

Proprietary names SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
Owner/operator DARLEYS SURGICAL CO.
Owner/operator number 9034166
Product codes GAF
Device names GAF - Spatula, Surgical, General & Plastic Surgery
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments DARLEYS SURGICAL CO.
Establishment registrations 3001297506
FEI numbers 3001297506
Establishment operations Manufacturer
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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