GIOTTO CLASS 40000-yy

GUDID 18056977360035

IMS GIOTTO SPA

Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital
Primary Device ID18056977360035
NIH Device Record Keydb9dd79d-6ad0-4c86-a7ae-efc9619278e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIOTTO CLASS
Version Model NumberGIOTTO CLASS S 3D
Catalog Number40000-yy
Company DUNS437701793
Company NameIMS GIOTTO SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056977360038 [Primary]
GS118056977360035 [Package]
Contains: 08056977360038
Package: [1 Units]
In Commercial Distribution
GS128056977360032 [Package]
Contains: 08056977360038
Package: [1 Units]
In Commercial Distribution
GS138056977360039 [Package]
Contains: 08056977360038
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull Field Digital, System, X-Ray, Mammographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-31
Device Publish Date2021-03-23

On-Brand Devices [GIOTTO CLASS ]

18056977360059GIOTTO CLASS S 2D
18056977360042GIOTTO CLASS S READY
18056977360035GIOTTO CLASS S 3D
08056977360021GIOTTO CLASS 2D
18056977360011GIOTTO CLASS 3D READY
18056977360004GIOTTO CLASS 3D

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