DynaCare Tampons, Regular, Plastic Applicator

GUDID 00810180840651

Dynarex Corporation

Menstrual tampon, unscented

• Primary Device ID: 00810180840651
• NIH Device Record Key: bd69968e-58d6-4b8b-9372-8ca49cb4c99d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons, Regular, Plastic Applicator
• Version Model Number: 1357R-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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810180840651 [Unit of Use]
GS1	00840117328419 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-10-30
• Device Publish Date: 2024-03-06

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

• 08401173284198: 1357R-BULK
• 00810180840651: 1357R-BULK