Catalog Number

SR2-USA

Brand Name

SONICAID

Version/Model Number

SR2-USA

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

K183574

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

0121d88d-a551-47c4-85c4-1638878599cb

Public Version Date

February 27, 2020

Public Version Number

1

DI Record Publish Date

February 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-