Catalog Number

D-3001

Brand Name

AMD-RITMED DISTECH ALL GAUZE

Version/Model Number

D-3001

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

d7d726c2-bb1e-4fd4-bd44-ea76402fb10f

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Package DI Number

20686864053426

Quantity per Package

25

Contains DI Package

10686864053429

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case