MEDONE ULTRA

GUDID 18052286427988

Soft Tissue programmable automatic biopsy system 12G x 120mm

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18052286427988
• NIH Device Record Key: 222e7b06-450e-4aa9-a714-5a342a31b5bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDONE ULTRA
• Version Model Number: MU12120-K0
• Company DUNS: 440211428
• Company Name: MEDAX SRL UNIPERSONALE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052286427981 [Primary]
GS1	18052286427988 [Package]; Contains: 08052286427981; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192101

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-15

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