Catalog Number

-

Brand Name

EndoFLIP

Version/Model Number

EF-322N

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"

-

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

K120997,K120997

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Public Device Record Key

bb52ca1b-06df-4de0-a1df-3bf98b88e97f

Public Version Date

July 23, 2020

Public Version Number

7

DI Record Publish Date

August 02, 2016

Package DI Number

05391530810074

Quantity per Package

5

Contains DI Package

05391530810012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box