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Playtex 00216

by Edgewell Personal Care Brands, LLC

Playtex 00216 is a Class II device made by Edgewell Personal Care Brands, LLC, cleared under FDA 510(k) K111684 on 3 Feb 2012 and listed in FDA GUDID since 15 Feb 2019 (UDI-DI 00078300002161), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K111684

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00078300002161 UDI-DI Date15 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111684 Date3 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111684 decided 3 Feb 2012 Active
  • FDA GUDID UDI-DI 00078300002161 listed 15 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111684
  2. Listed FDA GUDID 00078300002161

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Playtex
Generic name
Menstrual tampon, scented
Model / reference
00216
Primary DI / UDI-DI
00078300002161
510(k) Number
FDA product code
HIL
GMDN term
Menstrual tampon, scented
Device class
Class II
Regulation number
884.5460
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Menstrual tampon, scented

Cleared under the same submission (K111684)

and 1 more cleared under K111684

Similar devices

Other devices filed under FDA product code HIL (TAMPON, MENSTRUAL, SCENTED, DEODORIZED).

Other devices from Edgewell Personal Care Brands, LLC

See all devices from Edgewell Personal Care Brands, LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)