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Playtex

FDA UDI

Class II (US FDA UDI)

by Edgewell Personal Care Brands, Llc

Identity

Trade Name
Playtex FDA UDI
Generic Name
Menstrual tampon, unscented FDA UDI
Device Name
SPORT 32CT MPK ODOR SHIELD 4/3 FDA UDI
Model / Reference
08254 FDA UDI
Description
SPORT 32CT MPK ODOR SHIELD 4/3 FDA UDI

Identifiers

Primary DI / UDI-DI
00078300082545 FDA UDI
510(k) Number
K111684 FDA UDI
FDA Product Code
HEB FDA UDI
GMDN Term
Menstrual tampon, unscented FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.5470 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Menstrual tampon, unscented

Playtex by Edgewell Personal Care Brands, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Menstrual tampon, unscented.

Cleared under the same submission

K111684 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edgewell Personal Care Brands, Llc

Sources (1)

  • FDA UDI 329f15b9-48e7-40bf-a2c4-4c74fe1a5a1b 34 fields · synced May 30, 2026