Catalog Number

3175-

Brand Name

Webril

Version/Model Number

3175

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

b9eda96a-245b-446e-a3e3-914c672c105d

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

00192253020598

Quantity per Package

6

Contains DI Package

00192253020581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE