Catalog Number

B-2104

Brand Name

LAP-BAND System Access Port I Kit

Version/Model Number

B-2104

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 20, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

6d2ce587-7999-4b3d-b82f-7ea1376da1e0

Public Version Date

November 23, 2020

Public Version Number

3

DI Record Publish Date

August 26, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-