Catalog Number

-

Brand Name

EYETEC

Version/Model Number

40-420-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"

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

21f6921a-28ea-494d-9c3d-6a9013494566

Public Version Date

November 03, 2021

Public Version Number

1

DI Record Publish Date

October 26, 2021

Package DI Number

10385640051580

Quantity per Package

20

Contains DI Package

00385640051583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box