Catalog Number

-

Brand Name

VIVE

Version/Model Number

LVA2026

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

EFS

Product Code Name

Unit, Oral Irrigation

Public Device Record Key

36390ecb-8b28-497b-8649-d2f6fa6e762c

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

10818323028963

Quantity per Package

30

Contains DI Package

00818323028966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case