FDA device listing

Retractor

FDA device listing 1728092211 · Medenvision

Key facts

Owner/operator Medenvision
Owner/operator number 10051140
Product codes GAD
Device names GAD - Retractor
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments MEDENVISION
Establishment registrations 3012396476
FEI numbers 3012396476
Establishment operations Foreign Exporter, 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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