Catalog Number

MAC3H

Brand Name

DR 100s

Version/Model Number

6013/100

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

K191884

Product Code

IZL

Product Code Name

System, x-ray, mobile

Public Device Record Key

bda8c395-395e-4648-8efc-12c80f2dd3bb

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-