Catalog Number

Q604007

Brand Name

FABCO

Version/Model Number

Q604007

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

6537f575-3219-4a42-9d83-62355246ec4d

Public Version Date

May 28, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2016

Package DI Number

50634303800217

Quantity per Package

20

Contains DI Package

30634303800213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box