Catalog Number

301

Brand Name

DMV Soft Lens Handler

Version/Model Number

301

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K830496,K830496

Product Code

KYE

Product Code Name

Inserter/Remover Contact Lens

Public Device Record Key

a008acc2-222e-452e-919b-b06a67806fc3

Public Version Date

April 14, 2020

Public Version Number

1

DI Record Publish Date

April 06, 2020

Package DI Number

00080875983110

Quantity per Package

10

Contains DI Package

00080875983011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-