DynaCare Tampons,Super,Plastic Applicator

GUDID 08401173287854

Unscented, Free of Dyes & Perfumes

DYNAREX CORPORATION

Menstrual tampon, unscented

• Primary Device ID: 08401173287854
• NIH Device Record Key: c0a89a19-6e85-494b-8a9c-87d04a1521f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons,Super,Plastic Applicator
• Version Model Number: 1357S
• 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	00840117328464 [Package]; Contains: 00840117328785; Package: [9 Units]; In Commercial Distribution
GS1	00840117328785 [Primary]
GS1	08401173287854 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222046

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: 2024-04-17
• Device Publish Date: 2024-04-09

On-Brand Devices [DynaCare Tampons,Super,Plastic Applicator ]

• 08401173287854: Unscented, Free of Dyes & Perfumes
• 00810180840200: Unscented, Free of Dyes & Perfumes