Catalog Number

-

Brand Name

Sheathes

Version/Model Number

50001-166

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

89f6511c-4827-4aa3-8162-ac273d1c9140

Public Version Date

January 10, 2020

Public Version Number

1

DI Record Publish Date

January 02, 2020

Package DI Number

20842418104284

Quantity per Package

3

Contains DI Package

10842418104287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE