Every Cycle

GUDID 00860007113727

Every Cycle reusable tampon applicator

Cycle LLC

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

• Primary Device ID: 00860007113727
• NIH Device Record Key: b40fc9c7-a3b6-454f-89c4-74d8812ef596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Every Cycle
• Version Model Number: 7000
• Company DUNS: 111488323
• Company Name: Cycle LLC
• Device Count: 1
• 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: false
• 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	00860007113727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211519

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: 2022-03-18
• Device Publish Date: 2022-03-10