Regular Tampons Plastic Applicator

GUDID 00840117328440

Not Sterile

DYNAREX CORPORATION

Menstrual tampon, unscented

• Primary Device ID: 00840117328440
• NIH Device Record Key: 3e3ff418-a2f0-4c91-8a65-510666a31535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regular Tampons Plastic Applicator
• Version Model Number: 1357R
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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	00810180841900 [Unit of Use]
GS1	00840117328440 [Package]; Contains: 00840117328778; Package: Case [9 Units]; In Commercial Distribution
GS1	00840117328761 [Unit of Use]
GS1	00840117328778 [Primary]
GS1	08401173287786 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192557
• 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: 2023-12-29
• Device Publish Date: 2023-12-21

Devices Manufactured by DYNAREX CORPORATION

• 00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO: 2025-08-27
• 00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.
• 00616784304212 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 18"x 16". Weight Capacity: 300 LB
• 00616784304311 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 20" x 16". Weight Capacity: 300 LB
• 00616784304410 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 22" x 18" Weight Capacity: 300 LB