Catalog Number

-

Brand Name

UniTip Catheter

Version/Model Number

K10433-00-12127

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2018

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003580

Product Code

FFX

Product Code Name

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Public Device Record Key

31a9a283-1e35-45a3-a611-815908d42317

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-