UNIVERSAL PLUS

GUDID 18056515880100

Soft Tissue Biopsy Needle 12G x 100mm

MEDAX SRL UNIPERSONALE

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18056515880100
• NIH Device Record Key: d675819a-e2f3-4a18-b025-7c9620548751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL PLUS
• Version Model Number: UP12100-00
• 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	08056515880103 [Primary]
GS1	18056515880100 [Package]; Contains: 08056515880103; 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: 2021-01-25
• Device Publish Date: 2021-01-15

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