Catalog Number

-

Brand Name

Mac-Lab

Version/Model Number

v6.9.6 R3

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

-

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

-

FDA Premarket Submission

K130626

Product Code

DQK

Product Code Name

COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Public Device Record Key

e672ae60-6306-441c-91e8-8a51584c5103

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-