Playtex

Basic Information

• Brand Name: Playtex
• Primary DI: 00078300081098
• Version / Model: 08109
• Company Name: EDGEWELL PERSONAL CARE BRANDS, LLC
• Labeler DUNS: 151179769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-01
• Public Version: 3
• Public Version Date: 2023-01-05
• Public Version Status: Update
• Public Device Record Key: 180cfe4b-6d18-471e-b78a-e24b3e19585a

Device Description

Playtex 18ct Reg Unscent Tampon

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEB	TAMPON, MENSTRUAL, UNSCENTED	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20078300081092	GS1		6	In Commercial Distribution
Primary	00078300081098	GS1
Package	10078300081095	GS1		2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K060981	000