Catalog Number

5561701

Brand Name

ORTHO

Version/Model Number

5561701

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK130006

Product Code

MZA

Product Code Name

TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

Public Device Record Key

1bc30c79-8d3c-4dd1-9278-d23c217687fc

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-