FDA device listing

Cora Tampons

FDA device listing 1895544380 · Lyv Life, Inc.

Key facts

Proprietary names Cora Tampons
Owner/operator Lyv Life, Inc.
Owner/operator number 10050173
Premarket submissions K151170
Product codes HEB
Device names HEB - Tampon, Menstrual, Unscented
Device class Class II
Classification regulations (21 CFR) 884.5470
Review panels Obstetrics/Gynecology
Registered establishments Lyv Life Inc.
Establishment registrations 3012097557
FEI numbers 3012097557
Establishment operations 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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