Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

9430

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)

-

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

-

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

2e3ead25-8495-401d-b71a-81d37c5a0b88

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

M75294301

Quantity per Package

40

Contains DI Package

M75294300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box