FNA FRANSEEN

GUDID 18055002906583

Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 80mm

MEDAX SRL UNIPERSONALE

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• Primary Device ID: 18055002906583
• NIH Device Record Key: 420c88a0-5c69-496a-89c5-11d37da418e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FNA FRANSEEN
• Version Model Number: FR22080-01
• 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	08055002906586 [Primary]
GS1	18055002906583 [Package]; Contains: 08055002906586; Package: [20 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: 2023-12-21
• Device Publish Date: 2023-12-13

On-Brand Devices [FNA FRANSEEN]

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• 18059174749368: Aspiration Needle for cytological and microhistological biopsies on soft tissue 20G x 60mm
• 18055002906583: Aspiration Needle for cytological and microhistological biopsies on soft tissue 22G x 80mm
• 18053329372029: Aspiration Needle for cytological and microhistological biopsies on soft tissue 20G x 80mm