Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

689-436

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

PZG

Product Code Name

Surgical Eye Tray

Public Device Record Key

b03bef0a-488d-4199-9b51-0111ada5234f

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

March 14, 2022

Package DI Number

M7526894361

Quantity per Package

40

Contains DI Package

M7526894360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE