BIOPSY DIGIT 9201-01M1

GUDID 08056977360090

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: 08056977360090
• NIH Device Record Key: 0aaac019-c7ff-445c-971b-6a8346c21350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSY DIGIT
• Version Model Number: BIOPSY DIGIT SL
• Catalog Number: 9201-01M1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056977360090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113607

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

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 CLASS: 2021-03-31
• 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