COX for MEDCUT

GUDID 18056515885310

Introducer Coaxial needle

MEDAX SRL UNIPERSONALE

Nonimplantable needle guide, single-use

• Primary Device ID: 18056515885310
• NIH Device Record Key: ff3e2c4e-4ae7-48d5-bd2f-6222ce38210f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COX for MEDCUT
• Version Model Number: CM16200-00
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056515885313 [Primary]
GS1	18056515885310 [Package]; Contains: 08056515885313; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-03-07

On-Brand Devices [COX for MEDCUT]

• 18056515885471: Introducer Coaxial neeedle
• 18056515885457: Introducer Coaxial needle
• 18056515885433: CM20100-00
• 18056515885396: Introducer Coaxial needle
• 18056515885372: Coaxial introducer needle
• 18056515885358: Introducer Coaxial needle
• 18056515885310: Introducer Coaxial needle
• 18056515885297: Introducer Coaxial needle
• 18056515885273: Introducer Coaxial needle
• 18055002909089: Introducer coaxial needle