Catalog Number

610-2365, 610-2365-5

Brand Name

CIV-Clear™ Transducer Cover

Version/Model Number

610-2365

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

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

K211270,K211270,K211270

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

d3656fde-aca4-4be6-8b23-5dc4b3f828b9

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

November 20, 2021

Package DI Number

00841436120302

Quantity per Package

24

Contains DI Package

10841436120309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-