Catalog Number

MV CY 100

Brand Name

PHAKOS

Version/Model Number

MV CY 100

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

K162756,K162756,K162756

Product Code

HRN

Product Code Name

Unit, Cryophthalmic, Ac-Powered

Public Device Record Key

0244ed76-ee25-4481-8cd4-016ea6d263fc

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

October 22, 2018

Package DI Number

B564MVCY1002

Quantity per Package

5

Contains DI Package

B564MVCY1000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box