Epitomee 2TAC-56

GUDID 07290017914015

Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When taken with water, Epitomee® releases compartments filled with gel particles that form a triangular shape in the stomach. The particles absorb water, and the compartments swell. This helps one feel full sooner and eat less. The Epitomee® capsule's action is purely mechanical and does not involve any chemical activity.

EPITOMEE MEDICAL LTD

Ingested gastric satiety device

• Primary Device ID: 07290017914015
• NIH Device Record Key: eef2e650-2a7e-4f70-9b17-2d89272738ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epitomee
• Version Model Number: 6.6
• Catalog Number: 2TAC-56
• Company DUNS: 514600985
• Company Name: EPITOMEE MEDICAL LTD
• Device Count: 56
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017914015 [Unit of Use]
GS1	27290017914019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240544

FDA Product Code

• QFQ: Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

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: 2025-04-30
• Device Publish Date: 2025-04-22

On-Brand Devices [Epitomee]

• 07290017914022: Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When t
• 07290017914015: Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When t