Duns Number:625064352
Device Description: PACKAGED LAP-BAND CAL TUBE (US)
Catalog Number
A-2017
Brand Name
LAP-BAND Calibration Tube
Version/Model Number
A-2017
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2015
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"
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
46cf38cb-8f0e-4b20-b731-159f4f7d6467
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 |