Velox Pro

GUDID 18055002900499

MEDAX SRL UNIPERSONALE

Nonimplantable needle guide, single-use

• Primary Device ID: 18055002900499
• NIH Device Record Key: 9bff9537-9c1e-40ed-8aac-6a5c6f7825d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velox Pro
• Version Model Number: VP20160-00
• 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: false
• 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	08055002900492 [Primary]
GS1	18055002900499 [Package]; Contains: 08055002900492; Package: Carton Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092338

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-21

On-Brand Devices [Velox Pro]

• 18056515887789: VP18250-C0
• 18055002900994: VP21160-C0
• 18055002900987: VP21100-C0
• 18055002900970: VP21160-00
• 18055002900949: VP21100-00
• 18055002900529: VP20200-C0
• 18055002900512: VP20200-00
• 18055002900505: VP20160-C0
• 18055002900499: VP20160-00
• 18055002900482: VP20100-C0
• 08055002900478: VP20100-00
• 18055002900468: VP20060-00
• 18055002900451: VP18200-C0
• 18055002900444: VP18200-00
• 18055002900437: VP18160-C0
• 18055002900420: VP18160-00
• 18055002900413: VP18100-C0
• 18055002900406: VP18100-00
• 18055002900390: VP18060-00
• 18055002900383: VP16200-C0
• 18055002900376: VP16200-00
• 18055002900369: VP16160-C0
• 18055002900352: VP16160-00
• 18055002900345: VP16100-C0
• 18055002900338: VP16100-00
• 18055002900321: VP14200-C0
• 18055002900314: VP14200-00
• 18055002900307: VP14160-C0
• 18055002900291: VP14160-00
• 08055002900287: VP14100-C0
• 18055002900277: VP14100-00
• 18055002900260: VP14060-00