Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)

GUDID 16932503534731

Maximum insertion portion diameter:2.3mm, Needle:19G,Maximum needle length:80mm

Micro-Tech (Nanjing) Co., Ltd.

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 16932503534731
• NIH Device Record Key: f00a1ba3-35bc-485d-899d-8ff4e7c2b31c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)
• Version Model Number: EUS-19-0-CS1
• Company DUNS: 530269083
• Company Name: Micro-Tech (Nanjing) Co., Ltd.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com
• Phone: 877-552-4027
• Email: info@micro-tech-usa.com

Device Dimensions

• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932503534734 [Primary]
GS1	16932503534731 [Package]; Contains: 06932503534734; Package: BOX [1 Units]; In Commercial Distribution
GS1	26932503534738 [Package]; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172309

FDA Product Code

• ODG: Endoscopic Ultrasound System, Gastroenterology-Urology

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)]

• 16932503534823: Maximum insertion portion diameter:1.8mm,Needle:25G,Maximum needle length:80mm,Working channel:
• 16932503534816: Maximum insertion portion diameter:1.8mm,Needle:25G,Maximum needle length:80mm,Working channel:
• 16932503534786: Maximum insertion portion diameter:1.8mm,Needle:22G,Maximum needle length:80mm,Working channel:
• 16932503534779: Maximum insertion portion diameter:1.8mm,Needle:22G,Maximum needle length:80mm,Working channel:
• 16932503534748: Maximum insertion portion diameter:2.3mm,Needle:19G,Maximum needle length:80mm, Working channel:
• 16932503534731: Maximum insertion portion diameter:2.3mm, Needle:19G,Maximum needle length:80mm