Catalog Number

A606

Brand Name

AMD-RITMED

Version/Model Number

A606

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

MHW

Product Code Name

DRESSING, COMPRESSION

Public Device Record Key

1b0f2608-037c-4a38-96ed-050747f22b5f

Public Version Date

February 13, 2019

Public Version Number

1

DI Record Publish Date

January 13, 2019

Package DI Number

20686864051583

Quantity per Package

4

Contains DI Package

12686864051584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case