Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB1088

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

ba9a6713-766b-4463-8f29-34c3b0bb2b5c

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 07, 2020

Package DI Number

10810041981827

Quantity per Package

50

Contains DI Package

00810041981820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case