Catalog Number

-

Brand Name

ITA

Version/Model Number

ITA

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

4ba1c775-7e18-43cd-932e-b5e99a57a79b

Public Version Date

October 10, 2022

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10627825000106

Quantity per Package

25

Contains DI Package

00627825000109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-