FDA device listing

PureWay Sharps Collector Container

FDA device listing 1293577121 · PureWay Compliance, Inc.

Key facts

Proprietary names PureWay Sharps Collector Container
Owner/operator PureWay Compliance, Inc.
Owner/operator number 10049948
Premarket submissions K231484
Product codes MMK
Device names MMK - Container, Sharps
Device class Class II
Classification regulations (21 CFR) 880.5570
Review panels General Hospital
Registered establishments PUREWAY COMPLIANCE, INC.
Establishment registrations 3011881552
FEI numbers 3011881552
Establishment operations Specification Developer
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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