DynaCare Tampons, Super Plus, Cardboard Applicator

GUDID 08401173287618

Unscented, Free Of Dyes & Perfumes

DYNAREX CORPORATION

Menstrual tampon, unscented

• Primary Device ID: 08401173287618
• NIH Device Record Key: 5fc2c590-e7ea-4fe8-8266-8f1fa32e9961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons, Super Plus, Cardboard Applicator
• Version Model Number: 1355SP
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• 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	00840117328433 [Package]; Contains: 00840117328761; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117328761 [Primary]
GS1	08401173287618 [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

On-Brand Devices [DynaCare Tampons, Super Plus, Cardboard Applicator]

• 08401173287618: Unscented, Free Of Dyes & Perfumes
• 00810180840637: Unscented, Free Of Dyes & Perfumes