Home GUDID B001RSM1101 ReShape® Integrated Dual Balloon System
Primary DI B001RSM1101
Brand ReShape® Integrated Dual Balloon System
Company RESHAPE MEDICAL, INC.
Model RSM110
Catalog number RSM110
Device description IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
Published 2016-03-10
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Sterile 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 B001RSM1101 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 B001RSM9001 ReShape™ Valve Sealant RSM900 RSM900 2015-08-25 B001RSM2101 ReShape™ Removal Catheter RSM210 RSM210 2015-08-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00191506049232 Orbera™ BOSTON SCIENTIFIC CORPORATION LTI 2026-06-04 00810010540119 Allurion™ Gastric Balloon System Allurion Technologies, Inc. LTI 2026-04-07 00810010540126 Allurion™ Filler Kit Allurion Technologies, Inc. LTI 2026-04-07 00810010540133 Allurion™ Stylet Allurion Technologies, Inc. LTI 2026-04-07 03665039001663 Endoline PUNC PRINCE MEDICAL LTI 2024-01-30 03665039005630 Extraction Kit PRINCE MEDICAL LTI 2024-01-30 00850007764500 ReShape Lap-Band® 2.0 FLEX, Standard Medtimo, Inc LTI 2024-01-22 00850007764517 ReShape Lap-Band® 2.0 FLEX, Large Medtimo, Inc LTI 2024-01-22 00850007764548 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard Medtimo, Inc LTI 2024-01-22 00850007764555 ReShape Lap-Band® 2.0, FLEX & Access Port, Large Medtimo, Inc LTI 2024-01-22 00850007764586 ReShape Lap-Band® 2.0, FLEX Tubing Kit Medtimo, Inc LTI 2024-01-22 00860005178803 Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTD LTI 2021-10-20 10850007764323 LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) Medtimo, Inc LTI 2021-04-01 10850007764330 LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) Medtimo, Inc LTI 2021-04-01 00850007764043 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard Medtimo, Inc LTI 2021-02-01 00850007764067 RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large Medtimo, Inc LTI 2021-02-01 00850007764609 LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764654 LAP-BAND® AP System Large with RapidPort® EZ Medtimo, Inc LTI 2021-02-01 00850007764906 RapidPort® EZ Port Applier Medtimo, Inc LTI 2021-01-01 00850007764173 LAP-BAND® System Calibration Tube ReShape Lifesciences Inc. LTI 2020-12-01 00859810006227 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006104 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 00859810006142 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006173 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006180 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006197 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006203 OBALON Touch™ Medtimo, Inc LTI 2019-02-20 10859810006224 OBALON® OBALON THERAPEUTICS, INC. LTI 2019-02-20 00859810006234 OBALON® Medtimo, Inc LTI 2019-02-20 00859810006241 OBALON® Medtimo, Inc LTI 2019-02-20
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