Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB2012

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

IPG

Product Code Name

Shoe, Cast

Public Device Record Key

e0feaf76-7ddd-4c45-bc89-8f8cc5f9d72e

Public Version Date

October 23, 2019

Public Version Number

1

DI Record Publish Date

October 15, 2019

Package DI Number

10818323029755

Quantity per Package

25

Contains DI Package

00818323029758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case