Catalog Number

-

Brand Name

N/A

Version/Model Number

500-01

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

650e6da7-5ba6-48f9-8c0c-1981c9e7431f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 14, 2016

Package DI Number

10810090013296

Quantity per Package

10

Contains DI Package

00810090013299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton