Catalog Number

B4412

Brand Name

AMD-RITMED ALL GAUZE

Version/Model Number

B4412

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

d296e0f9-4200-438d-a1af-4f991044d4bc

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

12686864053212

Quantity per Package

100

Contains DI Package

10686864053214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tray