Catalog Number

USB-OR

Brand Name

Ultramatrix EUS Radial Balloon for Olympus & Pentax

Version/Model Number

USB-OR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 22, 2018

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

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

5a038a95-1462-4de6-9022-7ecf1b1d383d

Public Version Date

March 18, 2020

Public Version Number

4

DI Record Publish Date

December 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-