Catalog Number

1750488

Brand Name

18L5S SMALL ARRAY LINEAR TRANSDUCER

Version/Model Number

18L5S SMALL ARRAY LINEAR TRANSDUCER

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2020

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

-

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

a401f318-590b-4c51-9d9b-58a315f39a91

Public Version Date

October 01, 2020

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-