Catalog Number

-

Brand Name

Vital Vue

Version/Model Number

8886828306

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

Yes

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

K883201,K883201

Product Code

HBI

Product Code Name

ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Public Device Record Key

d6ae4708-9ef1-4ff7-9a48-6448aac79cec

Public Version Date

April 19, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521176116

Quantity per Package

6

Contains DI Package

10884521176119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE