Catalog Number

A90322

Brand Name

AMD-RITMED

Version/Model Number

A90322

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

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

55bc536c-50a3-43ce-b87f-a37967724997

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

20686864039864

Quantity per Package

10

Contains DI Package

10686864039867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE