Catalog Number

6006-15GM3

Brand Name

GIOTTO IMAGE 3DL

Version/Model Number

MAW

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

K111434,K111434

Product Code

MUE

Product Code Name

Full Field Digital,System,X-Ray,Mammographic

Public Device Record Key

9426ebb4-ffe9-4f58-b7fe-4d6507156155

Public Version Date

October 07, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

18033837190032

Quantity per Package

1

Contains DI Package

08033837190035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

X003411