Catalog Number

RSM900

Brand Name

ReShape™ Valve Sealant

Version/Model Number

RSM900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2019

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

98b46b22-9f39-4168-8601-41af7e4abd9d

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

-