ProcedureKitCRF CRF-U1510S-K

GUDID 00811746032954

CRF Procedure Kit

CAMBRIDGE INTERVENTIONAL LLC

Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: 00811746032954
• NIH Device Record Key: 63041613-b9c2-4aba-91e9-c0f58ed40dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProcedureKitCRF
• Version Model Number: CRF-U1510S-K
• Catalog Number: CRF-U1510S-K
• 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: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811746032954 [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: 2022-07-14
• Device Publish Date: 2022-07-06

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