Catalog Number

RSM110

Brand Name

ReShape® Integrated Dual Balloon System

Version/Model Number

RSM110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 24, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P140012

Product Code

LTI

Product Code Name

Implant, Intragastric For Morbid Obesity

Public Device Record Key

3d14cfbb-2a23-4628-b3b4-713868218e7e

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-