Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA1067WHT

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

512290b9-ab67-4810-bbec-9f31663f6882

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Package DI Number

10818323020943

Quantity per Package

50

Contains DI Package

00818323020946

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case