FDA UDI
In Commercial Distribution
🇺🇸 United States
Epitomee
DI: 27290017914026
·
Model: 6.6
·
EPITOMEE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
14
Basic Information
- Brand Name
- Epitomee
- Primary DI
- 27290017914026
- Version / Model
- 6.6
- Catalog Number
- 2TAC-14
- Company Name
- EPITOMEE MEDICAL LTD
- Labeler DUNS
- 514600985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 14
- Record Status
- Published
- Publish Date
- 2025-04-22
- Public Version
- 1
- Public Version Date
- 2025-04-30
- Public Version Status
- New
- Public Device Record Key
- 56cbac9e-4784-4d55-bfa9-8794be1bd347
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | Gastroenterology, Urology | 876.5982 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48146 | Ingested gastric satiety device | An orally-administered device intended to facilitate weight loss and treat obesity through appetite control. It is designed to be swallowed before meals to form a viscous gel in the stomach and/or small intestine to increase distention, creating the sensation of fullness and causing the user to eat less. It may additionally slow down intestinal glucose absorption to improve glycaemic control. It typically includes natural or modified fibre which expands after absorbing water; it is available in tablet, capsule, and powder sachet forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07290017914022 | GS1 | ||||
| Primary | 27290017914026 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240544 | 000 |