DynaCare Tampons, Super Plus, Plastic Applicator

GUDID 00840117328471

Unscented, Free Of Dyes & Perfumes

DYNAREX CORPORATION

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented

• Primary Device ID: 00840117328471
• NIH Device Record Key: 5f8bd746-eb96-44aa-87ce-a6c720ec4173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaCare Tampons, Super Plus, Plastic Applicator
• Version Model Number: 1357SP
• 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	00840117328471 [Package]; Contains: 00840117328792; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117328792 [Primary]
GS1	08401173287922 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-15
• Device Publish Date: 2024-03-07

Devices Manufactured by DYNAREX CORPORATION

• 00616784358253 - DynaSafety Waterproof Adhesive Tape,1" x 10yd: 2024-05-23 Non-Sterile
• 00616784894027 - LabChoice SecureSafety Safety Blood Collection Sets, Sterile,: 2024-05-23 Non-Toxic,21G,3/4" Needle
• 00616784894126 - LabChoice SecureSafety Safety Blood Collection Sets, Sterile: 2024-05-23 Sterile-EO,23G,3/4" Needle, Non-Toxic
• 00616784894225 - LabChoice SecureSafety Safety Blood Collection Sets, Sterile: 2024-05-23 Non-Toxic,Sterile-EO,25G,3/4" Needle
• 00616784055411 - IV Pole Removable 2-Hook Hanger,4 Legs,Steel: 2024-05-20
• 00840117321243 - DynaRest @Home Innerspring Mattress: 2024-05-20 80" x 36" x 6"
• 00840117321168 - DynaRide Pediatric Wheelchair with Footrest 12": 2024-05-17
• 00840117321175 - DynaRide Pediatric Wheelchair with Footrest 14": 2024-05-17