FDA device listing

HyBase V6 Operating Table Accessories(Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit),HyBase V6…

FDA device listing 1191538493 · Mindray DS USA, Inc.

Key facts

Proprietary names HyBase V6 Operating Table Accessories(Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit),HyBase V6 Operating Table (Orthopaedic Extension Device kit-CF, Orthopaedic Extension Device kit),Operating Room Accessories Table Tray
Owner/operator Mindray DS USA, Inc.
Owner/operator number 10025908
Product codes JEA
Device names JEA - Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class Class I
Classification regulations (21 CFR) 878.4960
Review panels General & Plastic Surgery
Registered establishments MINDRAY DS USA, Inc.
Establishment registrations 2221819
FEI numbers 2221819
Establishment operations Complaint File Establishment, Contract 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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