FRED'S TAMPONS

GUDID 10084579122476

REGULAR SCENTED PLASTIC APPLICATOR TAMPONS

FRED'S, INC.

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