FDA device listing

Glucology Pocket Needle Container

FDA device listing 1778459916 · IBD Medical Trading Pty Ltd.

Key facts

Proprietary names Glucology Pocket Needle Container
Owner/operator IBD Medical Trading Pty Ltd.
Owner/operator number 10071858
Premarket submissions K190240
Product codes MMK
Device names MMK - Container, Sharps
Device class Class II
Classification regulations (21 CFR) 880.5570
Review panels General Hospital
Registered establishments IBD Medical Trading Pty Ltd.
Establishment registrations 3016815268
FEI numbers 3016815268
Establishment operations Foreign Exporter, Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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