FDA UDI
In Commercial Distribution
🇺🇸 United States
Plenity®
DI: 00860517002665
·
Model: MC0683
·
GELESIS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
56
Basic Information
- Brand Name
- Plenity®
- Primary DI
- 00860517002665
- Version / Model
- MC0683
- Company Name
- GELESIS, INC.
- Labeler DUNS
- 010729307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 56
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 1
- Public Version Date
- 2021-09-09
- Public Version Status
- New
- Public Device Record Key
- 96985905-723b-43dd-b494-3bf73f9368fb
Device Description
Super-absorbent hydrogel to aid in weight management. Welcome Kit.
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 | 00860517002634 | GS1 | ||||
| Primary | 00860517002665 | GS1 |
Customer Contacts
- Phone
- 1-844-753-6489
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN180060 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius