Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB)

GUDID 16932503534762

Maximum insertion portion diameter:2.3mm,Needle:19G,Maximum needle length:80mm,Working channel: Greater than or equal to 2.8mm,Working Length:1245~1285mm, FNB needle

Micro-Tech (Nanjing) Co., Ltd.

Ultrasound aspiration biopsy procedure kit

• Primary Device ID: 16932503534762
• NIH Device Record Key: 6a13ae93-c123-492c-a990-4662a60e1b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB)
• Version Model Number: EUS-19-1-CS2
• 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	06932503534765 [Primary]
GS1	16932503534762 [Package]; Contains: 06932503534765; Package: BOX [1 Units]; In Commercial Distribution
GS1	26932503534769 [Package]; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172309

FDA Product Code

• FCG: Biopsy Needle

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 [Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB)]

• 16932503534847: Maximum insertion portion diameter:1.8mm,Needle:25G,Maximum needle length:80mm,Working channel:
• 16932503534830: Maximum insertion portion diameter:1.8mm,Needle:25G,Maximum needle length:80mm,Working channel:
• 16932503534809: Maximum insertion portion diameter:1.8mm,Needle:22G,Maximum needle length:80mm,Working channel:
• 16932503534793: Maximum insertion portion diameter:1.8mm,Needle:22G,Maximum needle length:80mm,Working channel:
• 16932503534762: Maximum insertion portion diameter:2.3mm,Needle:19G,Maximum needle length:80mm,Working channel:
• 16932503534755: Maximum insertion portion diameter:2.3mm,Needle:19G,Maximum needle length:80mm,Working channel: