DynaCare Tampons, Regular, Cardboard Applicator

GUDID 08401173287472

Unscented, Free Of Dyes & Perfumes

DYNAREX CORPORATION

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented

• Primary Device ID: 08401173287472
• NIH Device Record Key: b1cf1343-2493-4938-8cd0-86a5621011cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons, Regular, Cardboard Applicator
• Version Model Number: 1355R
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 25
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117328402 [Package]; Contains: 00840117328747; Package: Case [9 Units]; In Commercial Distribution
GS1	00840117328747 [Primary]
GS1	08401173287472 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191666

FDA Product Code

• HEB: Tampon, Menstrual, Unscented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-15
• Device Publish Date: 2024-03-07

Devices Manufactured by DYNAREX CORPORATION

• 08401173287854 - DynaCare Tampons,Super,Plastic Applicator: 2024-04-17 Unscented, Free of Dyes & Perfumes
• 00860008059512 - IV Start Kit: 2024-04-10
• 00840117333215 - Instant Cold Pack, 4" x 5": 2024-04-08 For use whenever instant cold therapy is required
• 00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount: 2024-04-05
• 00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic: 2024-04-02 15" , Sterile
• 00840117333000 - XeroBurn Sterile Burn Dressing Blanket: 2024-04-02 30" x 35"
• 00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70": 2024-04-02 60"x 70"
• 00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95": 2024-04-02 70" x 95"