Catalog Number

08990418

Brand Name

Transducer Cover

Version/Model Number

8990418

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

K970515,K970515

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

89b28cf1-024d-442d-a8f1-ab5c9d75c05e

Public Version Date

March 22, 2022

Public Version Number

7

DI Record Publish Date

August 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-