MEDEASY

GUDID 18059174742680

Soft tissue semi-automatic biopsy needle 20G x 60mm

MEDAX SRL UNIPERSONALE

Side-notch biopsy gun handpiece/needle

• Primary Device ID: 18059174742680
• NIH Device Record Key: c8b9085f-a22c-4700-ab9f-c90d2c13e1a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDEASY
• Version Model Number: ML20060-00
• 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	08059174742683 [Primary]
GS1	18059174742680 [Package]; Contains: 08059174742683; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181803

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: 2024-10-17
• Device Publish Date: 2024-10-09

Devices Manufactured by MEDAX SRL UNIPERSONALE

• 18059174742680 - MEDEASY: 2024-10-17Soft tissue semi-automatic biopsy needle 20G x 60mm
• 18059174742680 - MEDEASY: 2024-10-17 Soft tissue semi-automatic biopsy needle 20G x 60mm
• 18059174749870 - MED-GUIDE 1: 2024-07-31 Disposable endocavity biopsy needle guide
• 18053329372029 - FNA FRANSEEN: 2023-12-21 Aspiration Needle for cytological and microhistological biopsies on soft tissue 20G x 80mm
• 18055002906583 - FNA FRANSEEN: 2023-12-21 Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 80mm
• 18059174749368 - FNA FRANSEEN: 2023-12-21 Aspiration Needle for cytological and microhistological biopsies on soft tissue 20G x 60mm
• 18059174749375 - FNA FRANSEEN: 2023-12-21 Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 60mm
• 18059174748651 - MEDONE: 2022-11-16 Soft Tissue Automatic Biopsy System 18G x 250mm
• 18059174748606 - UNIVERSAL PLUS: 2022-11-15 Soft tissue biopsy needle compatible with reusable biopsy system 18G x 200mm