DynaCare Tampons Regular Cardboard Applicator

GUDID 08401173284570

Not-Sterile

DYNAREX CORPORATION

Menstrual tampon, unscented

• Primary Device ID: 08401173284570
• NIH Device Record Key: dcc3bee3-b1d3-4ed6-a39b-4eba810dea4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons Regular Cardboard Applicator
• Version Model Number: 1355R-Bulk
• 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	00840117328457 [Primary]
GS1	08401173284570 [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: 2024-08-02
• Device Publish Date: 2024-07-25

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