MEDONE

GUDID 18052283955699

Automatic soft tissue biopsy needle 20G x 200MM

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18052283955699
• NIH Device Record Key: e4dccadc-ff50-4afe-b185-a42c15df5310
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDONE
• Version Model Number: MO20200-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	08052283955692 [Primary]
GS1	18052283955699 [Package]; Contains: 08052283955692; 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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [MEDONE]

• 18052283955699: Automatic soft tissue biopsy needle 20G x 200MM
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• 18052283958997: Soft tissue automatic biopsy system 18G X 200mm
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• 18052286423645: Soft Tissue Automatic Biopsy System 18G X 160 mm
• 18052286423638: Soft Tissue Automatic Biopsy System 18G X 100 mm
• 18052286424345: Soft Tissue Automatic Disposable Biopsy System 18G x 250 mm
• 18052286424338: Soft Tissue Automatic DisposableBiopsy System 18G x 200 mm
• 18053329371367: Soft Tissue Automatic Biopsy System 20G x 250mm
• 18052286424031: Soft Tissue Automatic Biopsy System 20G x 250mm
• 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