Plenity™

Basic Information

• Brand Name: Plenity™
• Primary DI: 00860517002603
• Version / Model: MC0451
• Company Name: GELESIS, INC.
• Labeler DUNS: 010729307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 7
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 1
• Public Version Date: 2020-03-17
• Public Version Status: New
• Public Device Record Key: a8dd2178-e97c-4a24-93d1-ef521a1efcb8

Device Description

Super-absorbent hydrogel to aid in weight management.

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	00860517002627	GS1
Primary	00860517002603	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN180060	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius