Catalog Number

510.700.123

Brand Name

Procedure Pack Z8

Version/Model Number

10.0 CS Z8 S

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

K150323,K150323

Product Code

OOE

Product Code Name

Ophthalmic Femtosecond Laser

Public Device Record Key

b75de5ca-cd6a-4645-a85a-3be00ccd1bc9

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Package DI Number

07640167751310

Quantity per Package

10

Contains DI Package

07640167751372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton