Catalog Number

-

Brand Name

OBALON®

Version/Model Number

7404-0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

P160001

Product Code

LTI

Product Code Name

Implant, Intragastric For Morbid Obesity

Public Device Record Key

6e6b9843-b8da-459c-b979-17d1a3efc9c8

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

February 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-