Catalog Number

-

Brand Name

WF/EQ NA Vitrectomey Lens Set

Version/Model Number

OLIV-WENA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2018

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

-

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

K864418

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

1d6f3b3f-5f60-42c0-9969-77176086dfe0

Public Version Date

October 17, 2018

Public Version Number

4

DI Record Publish Date

December 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-