DynaCare Oraganic Tampons, Regular, Cardboard Applicator

GUDID 00810180842075

Regular: 6-9 G, Super 3-12 G, Super Plus: 12-15 G. Ingredients: 100% Organic Cotton (Wadding), 100% Organic Cotton (Non-Woven), Organic Cotton (Withdrawal Cord), Cardboard (Applicator). Warning: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.

Dynarex Corporation

Menstrual tampon, unscented

• Primary Device ID: 00810180842075
• NIH Device Record Key: 5c2175f6-1ee5-4b52-9525-523e8ba44e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Oraganic Tampons, Regular, Cardboard Applicator
• Version Model Number: 1378
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 500
• 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	00810180842075 [Unit of Use]
GS1	00840117343405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090819

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: 2025-06-13
• Device Publish Date: 2025-06-05

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