Catalog Number

F8M10S8A

Brand Name

F8M10S8A

Version/Model Number

F8M10S8A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 21, 2018

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

-

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

K934638

Product Code

JOP

Product Code Name

Transducer, Ultrasonic

Public Device Record Key

561812fc-71e4-442c-bbb0-6f382642f4bd

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

March 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-