Catalog Number

8886828106

Brand Name

Vital Vue

Version/Model Number

8886828106

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

6cc57e2c-4ea2-454a-97c1-b4634d6a82a8

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521176093

Quantity per Package

6

Contains DI Package

10884521176096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE