GeneratorCRF CRF

GUDID 00811746030622

CRF Radiofrequency Ablation Generator

CAMBRIDGE INTERVENTIONAL LLC

Radio-frequency ablation system Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator

• Primary Device ID: 00811746030622
• NIH Device Record Key: 1d4670cb-8600-4724-9987-cf77d96974cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeneratorCRF
• Version Model Number: CRF
• Catalog Number: CRF
• Company DUNS: 080897872
• Company Name: CAMBRIDGE INTERVENTIONAL 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: false
• 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

Customer Support Contacts

• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811746030622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192715

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by CAMBRIDGE INTERVENTIONAL LLC

• 00811746033159 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033166 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033173 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033180 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033197 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033203 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033210 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033227 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit