Catalog Number

-

Brand Name

Stradis

Version/Model Number

689-382R1

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

e2cb532b-20b0-44e4-8eba-638c459cb6a0

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

M752689382R11

Quantity per Package

10

Contains DI Package

M752689382R10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-