Catalog Number

B8125

Brand Name

AMD-RITMED ALL GAUZE

Version/Model Number

B8125

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

78a86b95-e860-4208-9cc3-c52e4c6dec24

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

12686864053250

Quantity per Package

10

Contains DI Package

10686864053252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tray