Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)

GUDID 16932503534700

Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm, FNA needle

Micro-Tech (Nanjing) Co., Ltd.

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 16932503534700
• NIH Device Record Key: a3c9d7ae-4965-430f-9541-bd8baadf17cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)
• Version Model Number: EUS-19-0-FS1
• 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
• 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
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932503534703 [Primary]
GS1	16932503534700 [Package]; Contains: 06932503534703; Package: BOX [1 Units]; In Commercial Distribution
GS1	26932503534707 [Package]; Package: CASE [5 Units]; In Commercial Distribution
GS1	36932503534704 [Package]; Contains: 26932503534707; Package: Transport Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212852

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) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)]

• 16932503534885: Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
• 16932503534861: Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure:
• 16932503534724: Maximum insertion portion diameter:2.2mm,Needle:22G,Maximum needle length:80mm,Needle structure:
• 16932503534700: Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: