Catalog Number

B-20390

Brand Name

RapidPort EZ Port Applier Tool

Version/Model Number

B-20390

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 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

0f1ef8b0-56ff-44bf-96fa-e243620d518a

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

-