MEDCUT

GUDID 18052283959123

Soft tissue automatic biopsy system 20G X 160mm

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18052283959123
• NIH Device Record Key: a71a8aac-559d-4417-883e-a4497d7abb1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDCUT
• Version Model Number: MC20160-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	08052283959126 [Primary]
GS1	18052283959123 [Package]; Contains: 08052283959126; 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: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [MEDCUT]

• 18052283959123: Soft tissue automatic biopsy system 20G X 160mm
• 18052286423621: Soft Tissue Automatic Biopsy System 18G X 160 mm
• 18052286423614: Soft Tissue Automatic Biopsy System 18G X 100 mm
• 18052286424246: Soft Tissue Automatic Biopsy System 20G X 200 mm
• 18052286424239: Soft Tissue Automatic Biopsy System 20G X 100 mm
• 18052286424949: Soft Tissue Automatic Biopsy System 20G x 250 mm