Catalog Number

-

Brand Name

Epsilon

Version/Model Number

E410

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 30, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130117,K130117

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

6ca07a5b-7892-4013-a255-b6f397a32632

Public Version Date

December 31, 2021

Public Version Number

4

DI Record Publish Date

August 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-