Catalog Number

K81759-E-2017-D

Brand Name

UniTip High Resolution Catheter

Version/Model Number

K81759-E-2017-D

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062222

Product Code

FFX

Product Code Name

System, Gastrointestinal Motility (Electrical)

Public Device Record Key

be502b2d-cfc5-4f37-bf73-54b1b511cb60

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

January 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-