RenaNav Video Processing Unit

GUDID 00810024670376

Video processing unit for RenaNav Single-Use Digital Flexible Ureteroscope

CENTERPOINT SYSTEMS LLC

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 00810024670376
• NIH Device Record Key: d1cd07fa-8e4e-4dd2-ac49-451aeb34503a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenaNav Video Processing Unit
• Version Model Number: NVS-MD-000386
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00810024670376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223097

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

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: 2024-04-23Video processing unit for RenaNav 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: 2023-03-27 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