DynaCare Tampons Regular Cardboard Applicator

GUDID 00810180840040

Not-Sterile

Dynarex Corporation

Menstrual tampon, unscented

• Primary Device ID: 00810180840040
• 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	00810180840040 [Unit of Use]
GS1	00840117328457 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-10-10
• Device Publish Date: 2024-07-25

On-Brand Devices [DynaCare Tampons Regular Cardboard Applicator ]

• 08401173284570: Not-Sterile
• 00810180840040: Not-Sterile