Every Cycle

GUDID 00860007113727

Every Cycle reusable tampon applicator

Cycle LLC

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