Catalog Number

17240

Brand Name

American White Cross

Version/Model Number

17240

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)

Yes

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

78004304-bc8d-4c3b-b82a-d57df37265ba

Public Version Date

May 23, 2022

Public Version Number

8

DI Record Publish Date

December 02, 2016

Package DI Number

20665973017765

Quantity per Package

20

Contains DI Package

10665973017768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case