Catalog Number

4519

Brand Name

Webril

Version/Model Number

4519

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

ab1548df-2aa8-44bc-adc6-cc33265db3dc

Public Version Date

September 03, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

20884527015358

Quantity per Package

36

Contains DI Package

10884527015351

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE