FDA device listing

NitWits All in One

FDA device listing 1074346820 · SI&D (Aust) Pty Ltd

Key facts

Proprietary names NitWits All in One
Owner/operator SI&D (Aust) Pty Ltd
Owner/operator number 10086480
Product codes PUN
Device names PUN - Lice Removal Kit Containing A Solution
Device class Class I
Classification regulations (21 CFR) 880.5960
Review panels General Hospital
Registered establishments SI&D (AUST) PTY LTD
Establishment registrations 3021499576
FEI numbers 3021499576
Establishment operations Complaint File Establishment, Specification Developer
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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