Duns Number:022894714
Device Description: OBALON® Balloon System - contains one Obalon Balloon Kit and one Obalon Accessory Kit
Catalog Number
-
Brand Name
OBALON® Balloon System
Version/Model Number
9500-0001
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,P160001
Product Code
LTI
Product Code Name
Implant, Intragastric For Morbid Obesity
Public Device Record Key
d6161536-099c-42f8-a781-08cbb9e502fb
Public Version Date
July 12, 2018
Public Version Number
5
DI Record Publish Date
December 26, 2016
Package DI Number
10859810006057
Quantity per Package
5
Contains DI Package
00859810006050
Package Discontinue Date
July 12, 2017
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 3 | A medical device with high risk that requires premarket approval | 16 |