FDA device listing

Handle, Scalpel

FDA device listing 1761721495 · MECMED MEDICAL

Key facts

Proprietary names Handle, Scalpel
Owner/operator MECMED MEDICAL
Owner/operator number 10078223
Product codes GDZ
Device names GDZ - Handle, Scalpel
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments MECMED MEDICAL
Establishment registrations 3016825318
FEI numbers 3016825318
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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