COX

GUDID 18052286423454

Coaxial Introducer Needle for biopsies on soft tissue, for Medone Ultra 12G X 160 mm

MEDAX SRL UNIPERSONALE

Nonimplantable needle guide, single-use

• Primary Device ID: 18052286423454
• NIH Device Record Key: d5ff3eb7-d6da-4745-b3d0-c218ec0040f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COX
• Version Model Number: CT12160-10
• 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	08052286423457 [Primary]
GS1	18052286423454 [Package]; Contains: 08052286423457; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142125

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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