MEDEXTRA

GUDID 18054301667065

Lymph node biopsy system with rectangular shaped cannula andadjustable penetration depth 4.6 x 2.10mm 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

• Primary Device ID: 18054301667065
• NIH Device Record Key: b2942b20-8661-41bb-aab5-a382a8efed4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDEXTRA
• Version Model Number: XT00100-00
• 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	08054301667068 [Primary]
GS1	18054301667065 [Package]; Contains: 08054301667068; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192101

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: 2020-09-29
• Device Publish Date: 2020-09-21

Devices Manufactured by MEDAX SRL UNIPERSONALE

• 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
• 18059174748613 - UNIVERSAL PLUS: 2022-11-15 Soft tissue biopsy needle compatible with reusable biopsy system 18G x 250mm
• 18059174748620 - FNA CHIBA: 2022-11-15 Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 200mm