FRED'S TAMPONS

Basic Information

• Brand Name: FRED'S TAMPONS
• Primary DI: 00084579122479
• Version / Model: FR11806SO
• Company Name: FRED'S, INC.
• Labeler DUNS: 005866116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 18
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 670b0c3d-5ff7-4fed-abf8-345a3a6f550c

Device Description

REGULAR SCENTED PLASTIC APPLICATOR TAMPONS

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HIL	Tampon, Menstrual, Scented, Deodorized	Obstetrics/Gynecology	884.5460	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32683	Menstrual tampon, scented	A 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	10084579122476	GS1	CASE	6	In Commercial Distribution
Primary	00084579122479	GS1
Unit of Use	00008457912242	GS1

Premarket Submissions

Submission Number	Supplement Number
K050067	000