Home GUDID B001RSM9001 ReShape™ Valve Sealant
Primary DI B001RSM9001
Brand ReShape™ Valve Sealant
Company RESHAPE MEDICAL, INC.
Model RSM900
Catalog number RSM900
Device description ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon
Published 2015-08-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
Single use true
Product Codes# Code, Name table Code Name LTI Implant, Intragastric For Morbid Obesity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTI Implant, Intragastric For Morbid Obesity Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B001RSM9001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Appetite-suppression gastric balloon An expandable device intended to be inflated in the stomach to create a feeling of satiety and reduce the desire for food. The device is inserted via a catheter and may be retained in the stomach where it degrades over a period. Disposable devices dedicated to introduction may be included.
Regulatory Flags# DUNS number 877283486 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B001RSM1011 ReShape™ Integrated Dual Balloon System RSM101 RSM101 2015-08-25 B001RSM1101 ReShape® Integrated Dual Balloon System RSM110 RSM110 2016-03-10 B001RSM2101 ReShape™ Removal Catheter RSM210 RSM210 2015-08-25
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