Catalog Number

-

Brand Name

Battery

Version/Model Number

P18438-02

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"

-

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

K162288,K180704

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

7ad1228b-9f79-49ee-901a-32a0aa461413

Public Version Date

May 28, 2020

Public Version Number

1

DI Record Publish Date

May 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-