Catalog Number

8607004

Brand Name

5C1 Curved Array Transducer

Version/Model Number

5C1 Curved Array Transducer

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150342

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

01de26e1-0462-4d12-8827-d6b0eee9db65

Public Version Date

May 20, 2020

Public Version Number

4

DI Record Publish Date

February 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-