Catalog Number

-

Brand Name

EYETEC

Version/Model Number

ST40-456-USA

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

-

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

8ada3307-271e-4f69-be29-f65cc23fe7e7

Public Version Date

March 30, 2022

Public Version Number

1

DI Record Publish Date

March 22, 2022

Package DI Number

10385640069691

Quantity per Package

200

Contains DI Package

00385640069694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG