Catalog Number

-

Brand Name

Sheathes

Version/Model Number

50040-25364

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K990175,K990175,K990175

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

31858ca7-2348-470e-9b46-15422da7011a

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

February 28, 2018

Package DI Number

20842418102341

Quantity per Package

3

Contains DI Package

10842418102344

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE