Catalog Number

510.700.115

Brand Name

Procedure Pack Z8

Version/Model Number

10.0 CS Z8

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

023fbade-be69-4293-b15d-1207b153eb4e

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 14, 2018

Package DI Number

07640167751082

Quantity per Package

10

Contains DI Package

07640167750542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton