Catalog Number

-

Brand Name

Obalon Aspiration Adapter

Version/Model Number

6100-0004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Product Code

KOA

Product Code Name

Surgical Instruments, G-U, Manual (And Accessories)

Public Device Record Key

1b12c782-29fc-48d4-ba76-96a5d30514bf

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

August 09, 2018

Package DI Number

20859810006269

Quantity per Package

2

Contains DI Package

10859810006262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-