Catalog Number

-

Brand Name

VERA

Version/Model Number

3.3.2-2.13.0

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150462

Product Code

LXJ

Product Code Name

System, Optical Position/Movement Recording

Public Device Record Key

98b18c79-9809-4cc6-982e-6ba7ea47ba5e

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-