Playtex 08257
by Edgewell Personal Care Brands, LLC
Playtex 08257 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 3 Mar 2020 (UDI-DI 00078300082576), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00078300082576 | Date3 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111684 | Date3 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 00078300082576
- FDA 510(k) database K111684
Across registries
- FDA 510(k) K111684 decided 3 Feb 2012 Active
- FDA GUDID UDI-DI 00078300082576 listed 3 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K111684
- Listed FDA GUDID 00078300082576
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Playtex
- Generic name
- Menstrual tampon, unscented
- Model / reference
- 08257
- Primary DI / UDI-DI
- 00078300082576
- 510(k) Number
- FDA product code
- HEB
- GMDN term
- Menstrual tampon, unscented
- Device class
- Class II
- Regulation number
- 884.5470
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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