MAMMOBED 6100-06M1

GUDID 18056977360103

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 ID18056977360103
NIH Device Record Key69183bcb-9451-4043-8d1f-544f00b996cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAMMOBED
Version Model NumberMAMMOBED
Catalog Number6100-06M1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056977360106 [Primary]
GS118056977360103 [Package]
Contains: 08056977360106
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

Devices Manufactured by IMS GIOTTO SPA

08056977360113 - SMART FINDER 2023-07-03 The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspirati
18056977360004 - GIOTTO CLASS2021-03-31
18056977360011 - GIOTTO CLASS 2021-03-31
08056977360021 - GIOTTO CLASS 2021-03-31
18056977360035 - GIOTTO CLASS 2021-03-31
18056977360042 - GIOTTO CLASS 2021-03-31
18056977360059 - GIOTTO CLASS 2021-03-31
18056977360066 - GIOTTO IMAGE 2021-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.