Duns Number:022894714
Device Description: OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
Catalog Number
-
Brand Name
OBALON®
Version/Model Number
6200-0001
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)
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
93c43471-06ce-4542-9c36-6f451c3299f6
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |