Catalog Number

6501M1

Brand Name

GIOTTO IMAGE

Version/Model Number

GIOTTO IMAGE M

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

K012953,K012953

Product Code

MUE

Product Code Name

Full Field Digital, System, X-Ray, Mammographic

Public Device Record Key

01c2d02e-74e8-459a-9858-fdbdba02eccc

Public Version Date

March 31, 2021

Public Version Number

1

DI Record Publish Date

March 23, 2021

Package DI Number

18056977360080

Quantity per Package

1

Contains DI Package

08056977360083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-