Catalog Number

RAR2081

Brand Name

RAR Flexi Probe

Version/Model Number

RAR2081

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061831,K061831

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

a0b8f244-8412-46be-a243-e23c045ea44f

Public Version Date

April 12, 2019

Public Version Number

2

DI Record Publish Date

November 28, 2018

Package DI Number

EAMIRAR20811

Quantity per Package

5

Contains DI Package

EAMIRAR20810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-