Catalog Number

-

Brand Name

Volista

Version/Model Number

ARDVCS209016A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130513

Product Code

FSY

Product Code Name

Light, surgical, ceiling mounted

Public Device Record Key

6c41b943-51b0-458e-b4a6-8aff7496b4f3

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-