Catalog Number

6702

Brand Name

GIOTTO IMAGE

Version/Model Number

GIOTTO IMAGE SRA

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

IZH

Product Code Name

System, X-Ray, Mammographic

Public Device Record Key

d5e96c22-ff29-4e51-b3f4-903a0f314f6f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

18033837190117

Quantity per Package

1

Contains DI Package

08033837190110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

X006528