Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1053

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

IKX

Product Code Name

Aid, Transfer

Public Device Record Key

e608b1fd-6e31-47d6-8a8c-1019724617f3

Public Version Date

March 11, 2022

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

10818323020073

Quantity per Package

35

Contains DI Package

00818323020076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case