Catalog Number

4221-

Brand Name

Webril

Version/Model Number

4221

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ITG

Product Code Name

BANDAGE, CAST

Public Device Record Key

db115f0f-c52a-4e3f-ab02-cd8c1b60d8a3

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

50192253020289

Quantity per Package

6

Contains DI Package

20192253020288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE