Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1021

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

ILS

Product Code Name

Adaptor, Hygiene

Public Device Record Key

7d61b7f0-738f-4255-976f-ad49b8771077

Public Version Date

February 19, 2021

Public Version Number

1

DI Record Publish Date

February 11, 2021

Package DI Number

10810041985207

Quantity per Package

2

Contains DI Package

00810041985200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case