CPS Locator 3D, Medium Delivery Catheter

GUDID 00810024670123

Delivery Catheter and dilator

CENTERPOINT SYSTEMS LLC

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• Primary Device ID: 00810024670123
• NIH Device Record Key: 2c6f5582-3b3e-447b-988c-a316119c45c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPS Locator 3D, Medium Delivery Catheter
• Version Model Number: 600300385
• Company DUNS: 117126091
• Company Name: CENTERPOINT SYSTEMS LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810024670123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230363

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2023-03-27
• Device Publish Date: 2023-03-17

Devices Manufactured by CENTERPOINT SYSTEMS LLC

• 00810024670109 - RenaNav Single-Use Digital Flexible Ureteroscope: 2024-04-23 Single-use digital flexible ureteroscope
• 00810024670376 - RenaNav Video Processing Unit: 2024-04-23 Video processing unit for RenaNav Single-Use Digital Flexible Ureteroscope
• 00810024670291 - Helix Locking Tool: 2024-03-25
• 00810024670116 - CPS Locator 3D, Large Delivery System: 2023-03-27 Catheter and dilator
• 00810024670123 - CPS Locator 3D, Medium Delivery Catheter: 2023-03-27Delivery Catheter and dilator
• 00810024670123 - CPS Locator 3D, Medium Delivery Catheter: 2023-03-27 Delivery Catheter and dilator
• 00810024670130 - CPS Locator 3D Small Delivery Catheter: 2023-03-27 Delivery catheter & dilator
• 00810024670147 - CPS Locator 3D Large Extra Long Delivery Catheter: 2023-03-27 Delivery catheter and dilator
• 00810024670154 - CPS Locator 3D Medium Extra Long Delivery Catheter: 2023-03-27 Delivery catheter & dilator