Catalog Number

-

Brand Name

Manipulator Lester IOL

Version/Model Number

41-1006

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HNQ

Product Code Name

Hook, Ophthalmic

Public Device Record Key

03a422ae-6051-4975-94bf-a0eb88e79147

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

05060480402188

Quantity per Package

10

Contains DI Package

05060480407688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-