Catalog Number

-

Brand Name

Vive Precision

Version/Model Number

DMD1027GRY

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

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d6cc3bf5-11b1-4b21-9751-056e9be80e62

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 02, 2017

Package DI Number

10818323020929

Quantity per Package

20

Contains DI Package

00818323020922

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case