Catalog Number

003500-0047-251

Brand Name

Z Cartridge IOL Delivery System - Cartridge

Version/Model Number

Z28

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"

Yes

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

K123888,K123888

Product Code

MSS

Product Code Name

Folders And Injectors, Intraocular Lens (Iol)

Public Device Record Key

f79a5af4-6873-4409-9994-ae1da6344221

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-