ReShape™ Integrated Dual Balloon System RSM101

GUDID B001RSM1011

IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY

RESHAPE MEDICAL, INC.

Appetite-suppression gastric balloon
Primary Device IDB001RSM1011
NIH Device Record Keyaedf4335-a29c-4c80-a7f0-1597ffae9327
Commercial Distribution StatusIn Commercial Distribution
Brand NameReShape™ Integrated Dual Balloon System
Version Model NumberRSM101
Catalog NumberRSM101
Company DUNS877283486
Company NameRESHAPE MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-844-937-7372
Emailcustomerservice@reshapemedical
Phone1-844-937-7372
Emailcustomerservice@reshapemedical
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com
Phone1-844-937-7372
Emailcustomerservice@reshapemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB001RSM1011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LTIImplant, Intragastric For Morbid Obesity

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-08-25

Devices Manufactured by RESHAPE MEDICAL, INC.

B001RSM1011 - ReShape™ Integrated Dual Balloon System2018-07-06IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
B001RSM1011 - ReShape™ Integrated Dual Balloon System2018-07-06 IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
B001RSM1101 - ReShape® Integrated Dual Balloon System2018-07-06 IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY
B001RSM2101 - ReShape™ Removal Catheter2018-07-06 ReShape™ Removal Catheter - component to remove the ReShape™ Integrated Dual Balloon
B001RSM9001 - ReShape™ Valve Sealant2018-07-06 ReShape™ Valve Sealant - component for use with the ReShape™ Integrated Dual Balloon

Trademark Results [ReShape]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESHAPE
RESHAPE
98590038 not registered Live/Pending
Reshape Biotech Inc.
2024-06-07
RESHAPE
RESHAPE
97927047 not registered Live/Pending
Andis Company
2023-05-09
RESHAPE
RESHAPE
97012348 not registered Live/Pending
Hodges, Damian
2021-09-04
RESHAPE
RESHAPE
97012348 not registered Live/Pending
Reyes, Darlene
2021-09-04
RESHAPE
RESHAPE
90481372 not registered Live/Pending
Xu Tao INDIVIDUAL CHINA 4-3-202, Sihouhuang Street Jiangnan, Xiangxie Garden Jinhua CHINA 321000
2021-01-22
RESHAPE
RESHAPE
88939396 not registered Live/Pending
Reshape Wealth LLC
2020-05-29
RESHAPE
RESHAPE
88939389 not registered Live/Pending
Reshape Wealth LLC
2020-05-29
RESHAPE
RESHAPE
88928949 not registered Live/Pending
Reshape Wealth LLC
2020-05-22
RESHAPE
RESHAPE
88812034 not registered Live/Pending
Reshape Holdings LLC
2020-02-26
RESHAPE
RESHAPE
88812026 not registered Live/Pending
Reshape Holdings LLC
2020-02-26
RESHAPE
RESHAPE
88788834 not registered Live/Pending
Reshape Me, UAB
2020-02-07
RESHAPE
RESHAPE
87720169 5664722 Live/Registered
YE TIAN
2017-12-13

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