Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps

GUDID 00810024670260

Single use pancreaticobiliary scope

CENTERPOINT SYSTEMS LLC

Flexible video choledochoscope, single-use

• Primary Device ID: 00810024670260
• NIH Device Record Key: e3a610de-bd69-417a-b1db-0ff4b4e04b79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps
• Version Model Number: DFE-MD-000652
• Company DUNS: 117126091
• Company Name: CENTERPOINT SYSTEMS LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810024670260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233752

FDA Product Code

• FBN: Choledochoscope And Accessories, Flexible/Rigid

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: 2024-07-30
• Device Publish Date: 2024-07-22

Devices Manufactured by CENTERPOINT SYSTEMS LLC

• 00810024670987 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.
• 00810024670994 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671007 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671069 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671076 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671083 - CPS Locator 3D Delivery Catheter: 2025-07-15 The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillation leads.
• 00810024671199 - AuST Steerable Sheath: 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc
• 00810024671205 - AuST Steerable Sheath: 2025-03-19 The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, inc