Catalog Number

MV LV 43

Brand Name

PHAKOS

Version/Model Number

MV LV 43

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K173944,K173944

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

00609ef5-1fbf-422a-817f-3cbd8f0b27da

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Package DI Number

B564MVLV432

Quantity per Package

10

Contains DI Package

B564MVLV430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-