Duns Number:625064352
Device Description: LAP-BAND 9.75 with ACCESS PORT II, US
Catalog Number
B-2215
Brand Name
The LAP-BAND Adjustable Gastric Banding System with the Access Port II
Version/Model Number
B-2215
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 28, 2015
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"
Yes
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
-
Product Code
LTI
Product Code Name
Implant, Intragastric For Morbid Obesity
Public Device Record Key
cacd9e17-7485-4766-a9b6-feddb1a828f2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 26, 2014
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 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 34 |