Catalog Number

-

Brand Name

VitreQ

Version/Model Number

LF20.D02

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

-

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

9d10e523-487f-4942-b8bf-d2592797431d

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Package DI Number

08719214222055

Quantity per Package

5

Contains DI Package

08719214222062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box