Catalog Number

-

Brand Name

Sheathes

Version/Model Number

50001-305

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

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

ce61140e-6ba7-48e5-a0d1-c2b042267af5

Public Version Date

May 23, 2018

Public Version Number

2

DI Record Publish Date

March 07, 2018

Package DI Number

20842418102389

Quantity per Package

3

Contains DI Package

10842418102382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE