Home GUDID 00860517002634 Plenity™
Primary DI 00860517002634
Brand Plenity™
Company GELESIS, INC.
Model MC0420
Device description Super-absorbent hydrogel to aid in weight management.
Published 2020-05-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QFQ Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860517002641 Package GS1 4 In Commercial Distribution 00860517002658 Package GS1 4 In Commercial Distribution 00860517002665 Primary GS1 0 00860517002672 Primary GS1 0 10860517002631 Primary GS1 0 20860517002638 Primary GS1 0 00860517002634 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860517002641 00860517002641 860517002641 0860517002641 00860517002658 00860517002658 860517002658 0860517002658 00860517002665 00860517002665 860517002665 0860517002665 00860517002672 00860517002672 860517002672 0860517002672 10860517002631 10860517002631 20860517002638 20860517002638 00860517002634 00860517002634 860517002634 0860517002634
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 5 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 010729307 Device count 14 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# 
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