FDA device listing

DAVIES (R) GOLD SERIES DERMATOME,GD-103,GD-113,GS-102

FDA device listing 1197545448 · DE SOUTTER MEDICAL LTD.

Key facts

Proprietary names DAVIES (R) GOLD SERIES DERMATOME,GD-103,GD-113,GS-102
Owner/operator DE SOUTTER MEDICAL LTD.
Owner/operator number 9003610
Product codes GFD
Device names GFD - Dermatome
Device class Class I
Classification regulations (21 CFR) 878.4820
Review panels General & Plastic Surgery
Registered establishments DE SOUTTER MEDICAL LTD.
Establishment registrations 8043750
FEI numbers 3002948288
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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