Catalog Number

DIU600U095

Brand Name

TECNIS IOL

Version/Model Number

DIU600

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MJP

Product Code Name

LENS, INTRAOCULAR, TORIC OPTICS

Public Device Record Key

a9b4d2da-b93b-4f4f-9690-8de31a5e9e69

Public Version Date

July 08, 2021

Public Version Number

2

DI Record Publish Date

February 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-