MEDONE

GUDID 18052283958980

Soft Tissue Automatic Biopsy System 14G x 160mm

MEDAX SRL UNIPERSONALE

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 18052283958980
• NIH Device Record Key: 095ea874-53ce-4bf3-8886-577fdf3e6eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDONE
• Version Model Number: MO14160-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	08052283958983 [Primary]
GS1	18052283958980 [Package]; Contains: 08052283958983; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172344

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: 2022-08-12
• Device Publish Date: 2022-08-04

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• 18052286423973: Soft Tissue Automatic Biopsy System 18G x 250mm
• 18052283958980: Soft Tissue Automatic Biopsy System 14G x 160mm
• 18059174748644: Soft Tissue Automatic Biopsy System 18G x 200mm
• 18059174748651: Soft Tissue Automatic Biopsy System 18G x 250mm