FDA device listing

GLENOSPHERE INSERTER

FDA device listing 1031322608 · Single Source Medical LLC

Key facts

Proprietary names GLENOSPHERE INSERTER
Owner/operator Single Source Medical LLC
Owner/operator number 10043888
Product codes HYA
Device names HYA - Forceps, Wire Holding
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments SINGLE SOURCE MEDICAL LLC
Establishment registrations 3010386387
FEI numbers 3010386387
Establishment operations 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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