Catalog Number

0525

Brand Name

SOFT CELL® PVA Foam Surgical Spears

Version/Model Number

0525, 0525-A

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"

Yes

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

K082460,K082460,K082460,K082460

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

ca265c9f-fe0c-4d94-a2cf-465062bcaece

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2018

Package DI Number

20845819000162

Quantity per Package

15

Contains DI Package

10845819000165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton