Catalog Number

Q604230

Brand Name

FABCO

Version/Model Number

Q604230

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)

-

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

5a638c71-6356-4deb-b4d0-3e62543f7b48

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 01, 2016

Package DI Number

50634303800293

Quantity per Package

18

Contains DI Package

30634303800299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box