GIOTTO CLASS 30010-yy

GUDID 18056977360011

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 ID: 18056977360011
• NIH Device Record Key: 29df0394-aa3a-4380-b2ba-c0ad548c1bf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIOTTO CLASS
• Version Model Number: GIOTTO CLASS 3D READY
• Catalog Number: 30010-yy
• Company DUNS: 437701793
• Company Name: IMS GIOTTO SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056977360014 [Primary]
GS1	18056977360011 [Package]; Contains: 08056977360014; Package: [1 Units]; In Commercial Distribution
GS1	28056977360018 [Package]; Contains: 08056977360014; Package: [1 Units]; In Commercial Distribution
GS1	38056977360015 [Package]; Contains: 08056977360014; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200424

FDA Product Code

• MUE: Full Field Digital, System, X-Ray, Mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

On-Brand Devices [GIOTTO CLASS ]

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