Catalog Number

C-20390

Brand Name

RapidPort® EZ Port Applier

Version/Model Number

C-20390

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P000008,P000008

Product Code

LTI

Product Code Name

Implant, Intragastric For Morbid Obesity

Public Device Record Key

856ff5b7-f40e-43b9-aa3f-b6d4af73986c

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-