FRED'S TAMPONS

GUDID 10084579122476

REGULAR SCENTED PLASTIC APPLICATOR TAMPONS

FRED'S, INC.

Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented

• Primary Device ID: 10084579122476
• NIH Device Record Key: 670b0c3d-5ff7-4fed-abf8-345a3a6f550c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRED'S TAMPONS
• Version Model Number: FR11806SO
• Company DUNS: 005866116
• Company Name: FRED'S, INC.
• Device Count: 18
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00008457912242 [Unit of Use]
GS1	00084579122479 [Primary]
GS1	10084579122476 [Package]; Contains: 00084579122479; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050067

FDA Product Code

• HIL: Tampon, Menstrual, Scented, Deodorized

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-01
• Device Publish Date: 2016-09-13