MEDONE ULTRA

GUDID 18052286423263

Soft Tissue Programmable Automatic Biopsy System 12G X 100 mm

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18052286423263
• NIH Device Record Key: 88c52191-6c25-4128-a1f0-6d1caa745f2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDONE ULTRA
• Version Model Number: MU12100-00
• 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	08052286423266 [Primary]
GS1	18052286423263 [Package]; Contains: 08052286423266; 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: 2020-05-13
• Device Publish Date: 2020-05-05

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• 18052286423393: Soft Tissue Programmable Automatic Biopsy System 18G X 160 mm
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• 18052286423331: Soft Tissue Programmable Automatic Biopsy System 14G X 160 mm
• 18052286423324: Soft Tissue Programmable Automatic Biopsy System 14G X 100 mm
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• 18052286423300: Soft Tissue Programmable Automatic Biopsy System 12G X 160 mm
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• 18052286421689: Soft Tissue Programmable Automatic Biopsy System 18G X 200 mm
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• 18052286421658: Soft Tissue Programmable Automatic Biopsy System 18G X 100 mm
• 18052286421634: Soft Tissue Programmable Automatic Biopsy System 16G X 200 mm
• 18052286421627: Soft Tissue Programmable Automatic Biopsy System 16G X 160 mm
• 18052286421603: Soft Tissue Programmable Automatic Biopsy System 16G X 100 mm
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