COX for MEDONE

GUDID 08053329376082

Coaxial introducer needle

MEDAX SRL UNIPERSONALE

Nonimplantable needle guide, single-use

• Primary Device ID: 08053329376082
• NIH Device Record Key: 6d4015f4-b2f6-4a3c-811b-3b31a4e31212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COX for MEDONE
• Version Model Number: CO12100-00
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08053329376082 [Primary]

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: 2018-03-06

On-Brand Devices [COX for MEDONE]

• 18053329376430: Introducer Coaxial needle
• 18053329376416: Introducer Coaxial Needle
• 18053329376393: Introducer Coaxial needle
• 18053329376355: Introducer Coaxial Needle
• 18053329376331: Introducer Coaxial needle
• 18053329376287: Introducer Coaxial needle
• 08053329376266: Introducer Coaxial needle
• 18053329376249: Inroducer Coaxial needle
• 18053329376188: Introducer Coaxial needle
• 08053329376167: Inroducer coaxial needle
• 08053329376105: Coaxial Introducer needle
• 08053329376082: Coaxial introducer needle
• 18052283955675: Introducer coaxial needle
• 18052283955668: Introducer coaxial needle