Catalog Number

RSM101

Brand Name

ReShape™ Integrated Dual Balloon System

Version/Model Number

RSM101

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2019

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LTI

Product Code Name

Implant, Intragastric For Morbid Obesity

Public Device Record Key

aedf4335-a29c-4c80-a7f0-1597ffae9327

Public Version Date

September 17, 2020

Public Version Number

5

DI Record Publish Date

August 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-