Duns Number:625064352
Device Description: PRI PACK LAP-BAND ADJUSTMENT KIT (APOLLO)
Catalog Number
B-20310
Brand Name
LAP-BAND System Adjustment Kit
Version/Model Number
B-20310
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 20, 2020
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
11a30c89-69c5-4ba1-a31c-75a991a22f02
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
September 15, 2014
Package DI Number
30811955020019
Quantity per Package
10
Contains DI Package
10811955020015
Package Discontinue Date
November 20, 2020
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 |