Catalog Number

3489

Brand Name

Webril

Version/Model Number

3489

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

42530394-5d22-4e42-836b-b2c04a3f16bb

Public Version Date

September 02, 2020

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

00884527018324

Quantity per Package

36

Contains DI Package

00884527015316

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE