Catalog Number

-

Brand Name

VivePro

Version/Model Number

RHB1088SET

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101952,K101952

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

3976c831-c0ef-457f-98fe-d72bb6a6b4f2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 09, 2021

Package DI Number

10810041988567

Quantity per Package

4

Contains DI Package

00810041988560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case