Duns Number:022894714
Device Description: OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System
Catalog Number
-
Brand Name
OBALON® EzFill™ Can
Version/Model Number
8200-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2018
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
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
439dee7b-7e0a-4ece-819a-c7d5ec023aff
Public Version Date
September 12, 2018
Public Version Number
5
DI Record Publish Date
December 22, 2016
Package DI Number
10859810006019
Quantity per Package
10
Contains DI Package
00859810006012
Package Discontinue Date
August 17, 2018
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 |