Catalog Number

-

Brand Name

Sheathes

Version/Model Number

50040-485NS

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

721feaa6-91a4-4616-84ec-c8c967fbfc15

Public Version Date

May 23, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10842418101835

Quantity per Package

10

Contains DI Package

00842418101838

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG