Plenity®

Primary DI
00860517002665
Brand
Plenity®
Company
GELESIS, INC.
Model
MC0683
Device description
Super-absorbent hydrogel to aid in weight management. Welcome Kit.
Published
2021-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight LossGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860517002665PrimaryGS10
00860517002634Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860517002665008605170026658605170026650860517002665
00860517002634008605170026348605170026340860517002634

GMDN Terms#

Term, Definition table
TermDefinition
Ingested gastric satiety deviceAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-844-753-6489info@gelesis.com

Regulatory Flags#

DUNS number
010729307
Device count
56
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860517002631Plenity™ MC04202020-05-06
20860517002638Plenity®MC05602020-12-09
00860517002603Plenity™ MC04512020-03-09
00860517002672Plenity®MC06842021-09-01
00860517002634Plenity™ MC04202020-05-06
00860517002627Plenity™ MC04512020-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055162880078Plenity®GELESIS SRLQFQ2026-01-14
08055162880009Plenity®GELESIS SRLQFQ2026-01-14
27290017914019EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
27290017914026EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914015EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914022EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
00860517002672Plenity®GELESIS, INC.QFQ2021-09-01
20860517002638Plenity®GELESIS, INC.QFQ2020-12-09
10860517002631Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002634Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002603Plenity™ GELESIS, INC.QFQ2020-03-09
00860517002627Plenity™ GELESIS, INC.QFQ2020-03-09