Duns Number:625064352
Device Description: LAP-BAND Access Port Needle 3.5 inch Pouch
Catalog Number
B-20301
Brand Name
LAP-BAND
Version/Model Number
B-20301
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 2021
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
-
Product Code
LTI
Product Code Name
Implant, Intragastric For Morbid Obesity
Public Device Record Key
3ba8d8fd-5ee6-4ad6-bb4a-9a03dd06a88e
Public Version Date
December 30, 2021
Public Version Number
6
DI Record Publish Date
August 17, 2016
Package DI Number
20811955020418
Quantity per Package
10
Contains DI Package
10811955020411
Package Discontinue Date
December 17, 2021
Package Status
Not in Commercial Distribution
Package Type
Kit
| 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 |