Catalog Number

-

Brand Name

Landers HRI 20° Prism Vitrectomy Lens

Version/Model Number

OLV-6-HRI

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

K914117

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

f7e3d6a1-1101-46bf-91f8-af97beb4c0de

Public Version Date

October 17, 2018

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-