GIOTTO IMAGE 6907

GUDID 18056977360066

IMS GIOTTO SPA

Stationary mammographic x-ray system, digital
Primary Device ID18056977360066
NIH Device Record Key24a15ea6-8074-419f-aaab-d06092b9992d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIOTTO IMAGE
Version Model NumberGIOTTO IMAGE 3DL
Catalog Number6907
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
GS108056977360069 [Primary]
GS118056977360066 [Package]
Contains: 08056977360069
Package: [1 Units]
In Commercial Distribution
GS128056977360063 [Package]
Contains: 08056977360069
Package: [1 Units]
In Commercial Distribution
GS138056977360060 [Package]
Contains: 08056977360069
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 IMAGE ]

18056977360080GIOTTO IMAGE M
18056977360073GIOTTO IMAGE 3DL/3MP
18056977360066GIOTTO IMAGE 3DL

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