Catalog Number

-

Brand Name

VIVE

Version/Model Number

RHB1012S

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

IME

Product Code Name

Pack, Hot Or Cold, Reusable

Public Device Record Key

8b0dfc70-a585-4444-95e3-d70a7c368fc0

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 30, 2019

Package DI Number

10818323026105

Quantity per Package

20

Contains DI Package

00818323026108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case