FDA device listing

BackVive

FDA device listing 1252696381 · Steri-Tek

Key facts

Proprietary names BackVive
Owner/operator Steri-Tek
Owner/operator number 10051493
Product codes MQX
Device names MQX - Needle, Acupuncture, Single Use
Device class Class II
Classification regulations (21 CFR) 880.5580
Review panels General Hospital
Registered establishments STERI-TEK
Establishment registrations 3012448339
FEI numbers 3012448339
Establishment operations Contract Sterilizer
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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