MULTICORE MLC1825

GUDID 18033959225742

Automatic guillotine type instrument for soft tissue biopsy 18G; 25cm

STERYLAB SRL

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 18033959225742
• NIH Device Record Key: e5db5e87-c75e-4394-b650-913e6f28d6e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MULTICORE
• Version Model Number: MULTICORE
• Catalog Number: MLC1825
• Company DUNS: 439659574
• Company Name: STERYLAB SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033959225745 [Primary]
GS1	18033959225742 [Package]; Contains: 08033959225745; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051506

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: 2019-10-10
• Device Publish Date: 2019-10-02

On-Brand Devices [MULTICORE]

• 18033959225940: Automatic guillotine type instrument for soft tissue biopsy 20G; 25 cm
• 18033959225896: Automatic guillotine type instrument for soft tissue biopsy 20G; 20 cm
• 18033959225841: Automatic guillotine type instrument for soft tissue biopsy 20G; 15 cm
• 18033959225810: Automatic guillotine type instrument for soft tissue biopsy 20G; 11 cm
• 18033959225742: Automatic guillotine type instrument for soft tissue biopsy 18G; 25cm
• 18033959225667: Automatic guillotine type instrument for soft tissue biopsy 18G; 20cm
• 18033959225612: Automatic guillotine type instrument for soft tissue biopsy 18G; 15 cm
• 18033959225568: Automatic guillotine type instrument for soft tissue biopsy 18G; 11 cm
• 18033959225506: Automatic guillotine type instrument for soft tissue biopsy 16G;25cm
• 18033959225421: Automatic guillotine type instrument for soft tissue biopsy 16G;20cm
• 18033959225346: Automatic guillotine type instrument for soft tissue biopsy 16G; 15 cm
• 18033959225292: Automatic guillotine type instrument for soft tissue biopsy 16G; 11 cm
• 18033959225216: Automatic guillotine type instrument for soft tissue biopsy 14G; 25 cm
• 18033959225131: Automatic guillotine type instrument for soft tissue biopsy 14G; 20 cm
• 18033959225056: Automatic guillotine type instrument for soft tissue biopsy 14G; 15cm
• 18033959225001: Automatic guillotine type instrument for soft tissue biopsy 14G; 11 cm