Catalog Number

-

Brand Name

OBALON® Balloon Kit

Version/Model Number

7500-0001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2017

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

P160001

Product Code

LTI

Product Code Name

Implant, Intragastric For Morbid Obesity

Public Device Record Key

fe5d4074-d025-4231-b594-bce55836a01b

Public Version Date

July 12, 2018

Public Version Number

5

DI Record Publish Date

December 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-