Catalog Number

-

Brand Name

Sonic Window Sterile Transducer Cover

Version/Model Number

21-05012-01

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

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

K140126,K140126,K140126

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

e42cf25f-ff6c-4715-89fa-feed633e5c64

Public Version Date

December 21, 2018

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

90814277020134

Quantity per Package

50

Contains DI Package

90814277020127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-