Catalog Number

-

Brand Name

Vive

Version/Model Number

LVA2097SLV

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

32f244ff-d20a-4a12-bc38-6aef02463708

Public Version Date

November 03, 2021

Public Version Number

1

DI Record Publish Date

October 26, 2021

Package DI Number

10810041987829

Quantity per Package

5

Contains DI Package

00810041987822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case