FDA device listing

FreeHold Duo Hands-Free Intracorporeal Retractor,FreeHold Trio Hands-Free Intracorporeal Retractor

FDA device listing 1106181507 · Freehold Surgical, LLC

Key facts

Proprietary names FreeHold Duo Hands-Free Intracorporeal Retractor,FreeHold Trio Hands-Free Intracorporeal Retractor
Owner/operator Freehold Surgical, LLC
Owner/operator number 10047234
Product codes GAD
Device names GAD - Retractor
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments FREEHOLD SURGICAL, INC.
Establishment registrations 3011050528
FEI numbers 3011050528
Establishment operations Complaint File Establishment, Specification Developer
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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