Catalog Number

9000639

Brand Name

Henry Schein

Version/Model Number

9000639

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)

Yes

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

K022156,K022156

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

1acdd223-5d07-4075-9464-dd938d4d3a03

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-