Catalog Number

-

Brand Name

NA

Version/Model Number

RAB2-5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 09, 2019

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

K041688

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

cd507272-bea0-4c99-9ad8-0c62e27ba8b8

Public Version Date

May 11, 2020

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-