Catalog Number

5004-B

Brand Name

AMD-RITMED

Version/Model Number

5004-B

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

73539bf4-f0f4-44e9-aa94-22117dc83aab

Public Version Date

February 15, 2019

Public Version Number

1

DI Record Publish Date

January 15, 2019

Package DI Number

20686864021814

Quantity per Package

20

Contains DI Package

10686864021817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case