SMART FINDER

GUDID 08056977360113

The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement.

IMS GIOTTO SPA

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 08056977360113
• NIH Device Record Key: b8019d08-cacb-499f-b451-d945c210f1a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART FINDER
• Version Model Number: 28000-02
• 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	08056977360113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203509

FDA Product Code

• IZH: 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: 2023-07-03
• Device Publish Date: 2023-06-25

Devices Manufactured by IMS GIOTTO SPA

• 08056977360113 - SMART FINDER: 2023-07-03The SMART FINDER is intended to be used for mammographic procedures requiring stereotactic guidance,such as fine needle aspiration, needle biopsy and guide wire placement.
• 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