Catalog Number

-

Brand Name

N/A

Version/Model Number

600-08

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

008a0419-2ac5-4537-91ef-35302fb9399c

Public Version Date

September 24, 2021

Public Version Number

3

DI Record Publish Date

October 28, 2016

Package DI Number

10810090014163

Quantity per Package

20

Contains DI Package

00810090014166

Package Discontinue Date

September 24, 2021

Package Status

Not in Commercial Distribution

Package Type

carton