Catalog Number

-

Brand Name

N/A

Version/Model Number

LS5288

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

7037b967-990b-4532-aec3-34d75205a5a2

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

80092237613258

Quantity per Package

24

Contains DI Package

00092237613252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA