FDA device listing

Cartwheel Nit Happens Lice Treatment Kit

FDA device listing 1596713452 · Freezenit, Inc.

Key facts

Proprietary names Cartwheel Nit Happens Lice Treatment Kit
Owner/operator Freezenit, Inc.
Owner/operator number 10095400
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 FREEZENIT, INC.
Establishment registrations 3043648637
FEI numbers 3043648637
Establishment operations 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

Browse all FDA device listings