Catalog Number

-

Brand Name

ABX MICROS ES60 OT

Version/Model Number

1280070022, 1280070023

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141161

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

84516ad4-5ff6-48da-b8d4-f48b6aafc516

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-