UNIVERSAL PLUS

GUDID 18059174748613

Soft tissue biopsy needle compatible with reusable biopsy system 18G x 250mm

MEDAX SRL UNIPERSONALE

Side-notch biopsy gun needle

• Primary Device ID: 18059174748613
• NIH Device Record Key: 0816c005-86ba-4445-803a-950c81be5089
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL PLUS
• Version Model Number: UP18250-00/M
• 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	08059174748616 [Primary]
GS1	18059174748613 [Package]; Contains: 08059174748616; Package: [10 Units]; In Commercial Distribution

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: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [UNIVERSAL PLUS]

• 18056515880117: Soft Tissue Biopsy Needle 14G x 100mm
• 18056515880100: Soft Tissue Biopsy Needle 12G x 100mm
• 18059174748613: Soft tissue biopsy needle compatible with reusable biopsy system 18G x 250mm
• 18059174748606: Soft tissue biopsy needle compatible with reusable biopsy system 18G x 200mm