Catalog Number

610-2423

Brand Name

Transducer Cover

Version/Model Number

610-2423

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

K013721,K013721,K013721

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

23017272-111c-4cd5-8ba9-8b3ceefc87cb

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 20, 2021

Package DI Number

00841436121651

Quantity per Package

250

Contains DI Package

10841436121658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-