Duns Number:022894714
Device Description: OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessor OBALON® Balloon System HPMC - contains one Obalon Balloon Kit HPMC and one Obalon Accessory Kit
Catalog Number
-
Brand Name
OBALON® Balloon System HPMC
Version/Model Number
9600-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2020
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
35ef00f3-0d4b-4c50-9e53-f07a4005c6b7
Public Version Date
May 25, 2020
Public Version Number
5
DI Record Publish Date
July 11, 2017
Package DI Number
10859810006071
Quantity per Package
5
Contains DI Package
00859810006074
Package Discontinue Date
March 02, 2020
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 |