Catalog Number

-

Brand Name

N/A

Version/Model Number

LS5255

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"

Yes

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

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

75f9570a-a15b-4cd6-9a57-66fc0fe4c81a

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

80092237611537

Quantity per Package

4

Contains DI Package

00092237611531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA